text:
* Shake mobile device (up and down) to charge spray
* Touch nozzle to emulate spraying paint
Internet & GPS permissions for ads.
What's New
Graffiti Tag Marker
Graffiti tag marker is an intuitive, multitouch, pressure-sensitive drawing app that emulate graffiti ink strokes!
With great tips and flow, choose your favourite nib; slim, mop or jumbo and get creative!
Pro version now available! $0.99
( Ad-free + New drip effects)
- Pressure sensitivity ( allow to draw a thicker or thinner line )
- Store your art in the photo library of your device and Share!
also avaible FREE for your iPhone http://apple.co/1NjU5yn
Spray Can - Sketch,Draw,Paint
★ publish your art in our unique online gallery
★ chat with thousands of users from all over the world
★ rate and comment on other user's tags
★ build your own fan base and become famous
★ show your art to the world on spray-can.com
✩ Spray Can Overview ✩
• multiple community features: create your own profile, follow users and let them follow you
• easy, yet creative paint mode with 13 backgrounds, 54 prefabricated colors and color wheel
• online gallery with more than 6.5 million pictures
• thousands of new pictures and comments every day
✩ Create your own Profile ✩
Spray Can is a community, so as a community member you need a profile. We don't need much information. You can simply enter your nickname and choose a profile picture out of your tags. Here we go! Now you can upload your tags, observe the number of points and followers you are gaining, get comments in your guestbook and write on other people's walls.
✩ Paint your own Pictures ✩
To show your skills you can choose between up to 13 backgrounds and 54 prefabricated colors for your tags. Besides we added a color wheel, which allows you to define and safe the precise colors you need. On top of that you can use a bunch of tools to create even more amazing pictures, such as different shapes, drips and a smoothly changeable size of your line and outline. Some users spend hours, sometimes even days to create their impressive art works.
✩ View the amazing gallery ✩
You can browse through an online gallery with more than 6.5 million pictures. Here you can view the most popular tags, share your opinions by commenting on other pictures, follow your favorites or swap ideas via chat. And every single day there are about 20.000 new amazing artworks arising, waiting to be discovered.
You want to become a famous artist as well? So, what are you waiting for..?
My Paints Free
Get an ad-free painting tool for free!
My Paints Free is one of the best painting tools for children and adults. It contains
many brushes (over 30) and other features, such as eraser, undo/redo, image
loading/saving/sharing, and more!
★ The Pro version includes all features of the My Paints free version but has a newer
version (with new features added) and new brushes ★
Main benefits:
• Contains no ads, no spyware.
• Tools including various brushes, eraser, filler, color picker (with transparency
• The application supports the most types of Android phones and tablets.
• "My paints" saves edited photos and new pictures into SD-card.
• You can load pictures and photos from the gallery.
• Kids mode included (random color changing).
• The sharing feature is added: you can share your artwork with your friends in Google
+, Facebook, Picasa, DropBox, Facebook, Gmail, etc; via MMS, e-mail, Bluetooth (firstly
you may need to install these apps).
• You can continue to edit your last unsaved artwork next day after new start of the
• Undo/Redo features are included.
• You can play your activities with embedded player
My Xbox LIVE
This app will allow you to…
• Track and compare your achievements with your LIVE friends
• Change up your 3D avatar
• Message your Xbox LIVE friends
• Edit your LIVE Profile
This app requires an Xbox LIVE account to sign in. Available for most Android 2.2+ smartphones, with WGVA screen resolution or higher.
What are you waiting for? Let's get APPIN' already – you can download now! Oh, and watch out for those Do Not Touch buttons!
Watch full episodes of your favorite shows from your Android phone or tablet:
• SpongeBob SquarePants
• The Legend of Korra
• Teenage Mutant Ninja Turtles
• Power Rangers
• Sanjay & Craig
• iCarly
• Sam & Cat
• Victorious
• Every Witch Way
• Breadwinners
• The Thundermans
• The Fairly OddParents
• Haunted Hathaways
• And More!
Watch even more full episodes and cartoons with select cable providers. If you don't see your provider, check back often. We are adding new providers all the time!
• Fun Overload: Swipe to explore and let your fingers point the way to fun.
• Laugh-Out-Loud Original Videos: Hungry for funny? Get ready for tons of brand new wild and wacky videos featuring your favorite Nick characters and stars! Videos are updated daily.
• Games: Love games? We've got loads of them! Prepare to be entertained for hours. Play on!
• Animated Shorts: Watch all-new animated shorts featuring SpongeBob, Teenage Mutant Ninja Turtles, Power Rangers, Sanjay & Craig and more!
• Full Episodes: Missed the latest episode? Now, you can watch recent episodes of Nick shows by logging in with your TV provider.
• Polls: Would you rather have Patrick's brains or Squidward's mood? Take these fast and funny polls and cast your vote.
• Surprising Surprises: Keep exploring to discover new, hilarious surprises from Nick. Just look out for SLIME!
• Epic Event Coverage: Not by your TV? Watch Nickelodeon events like the Kids' Choice Awards and Kids' Choice Sports right from the Nick app so you don't miss a second of celebs or slime.
The Nick App collects personal user data as well as non-personal user data (including aggregated data). User data collection is in accordance with applicable law, such as COPPA. User data may be used, for example, to respond to user requests; enable users to take advantage of certain features and services; personalize content and advertising; and manage and improve Nickelodeon's services. When cable television service subscribers authenticate their cable television service to view full episodes, a third-party token is stored on the device. For more information regarding Nickelodeon's use of personal user data, please visit the Nickelodeon Group Privacy Policy below. Our Privacy Policy is in addition to any terms, conditions or policies agreed to between you and Google, Inc., and Nickelodeon and its affiliated entities are not responsible for Google's collection or use of your personal user data and information. Use of this app is subject to the Nickelodeon End User License Agreement.
Privacy Policy: http://www.nick.com/info/privacy-policy.html
End User License Agreement: http://www.nick.com/info/eula.html
Having trouble with the Nick app or just have a question? Check out the Nick app Support page! http://appsupport.nick.com/
This Application provide you various tools for give direction to your creative Mind, It has different brushes and various backgrounds for make Pic.
Key Features
- Auto Mode for give automatic effects to your Photo
- Various brushes for give effects like Gradient, Shades, Blur, Emboss etc.
- Easy to erase
- Undo-Redo any move at each Point
- Various Stroke Patterns
- Various background colors and frames to make Perfect Pic
- Share your creativity with Friends using Social Medias
Graffiti creator!
Add your photo, choose the background wall , add text, use the spray paints, save your creation and share its with your friends or use its like a wallpaper! let your imagination run free.
The main features are:
- Blend a photo on a wall
- Change the type of blending(dark or light)
- Choice of Wall
- Adjusting the contrast
- Set gray level images
- Zoom / unzoom, rotation, mirror effect
- Add text with color choice
- Add spray paint with choice of colors
- Save your creation
- Share its creation by email or Facebook
Vinylmation: Create Your Own
Draw inspiration from the trailer and behind the scenes clip of the short film, Blank: A Vinylmation Love Story.
Note: All text within the application is presented in English.
Sketch Kit - Drawing App
You can start with a blank canvas or enhance an existing file.
Draw, paint, add text, or choose from our library of fun animations.
Whether want to enhance a photo, add notations to a map, or create something original, Sketch Kit is the perfect tool!
Once your masterpiece is complete, you can share it instantly with Yooii Connector.
Send it to a friend or use our fun "Message in a Bottle" theme button to send it to a random user somewhere in the world.
- Send and Receive images.
- Share your art with random users anywhere in the world.
- Easily enhance existing image
- Create new images on a blank canvas
- Tons of choices of pens and brushes with various thicknesses
- Enhance photos with text, stickers, animations and photos
- Add themes like Snow, Star, Flowers and Hearts etc
- Lots of great animation effects, including: shaking, blinking, and stretching
Photo & Camera:
- Use your own photos as a background or insert them into any image
- Enhance or edit pictures immediately after you take them
Web & Map:
- You can instantly capture webpages and maps and enhance them.
Sketch Kit converts your smart phone/tablet into a sketchbook.
Share your art with friends instantly.
Sketch Kit supports smartphones, 7" and 10" tablets
Sketch Kit is powered by Yooii Connector.
About permissionst:
Gallery: When the user selects 'Photo', Sketch Kit accesses device photos so photos can be used as a canvas.
Camera: Smartphone/Tablet camera is accessed when the user selects 'Camera' so photos can be used as a canvas.
Location Services: When the user selects 'Map', Location Services are used to determine the current location so the map can be used as a canvas.
External Storage: If an SD card or other external storage is connected, the user may opt to Save Image to that storage device.
Drawing and Painting
Finger Painting, Kids coloring, Brush paint, Spray, Image painting, Draw, Draw it, Simple, easy, fun and finger painting. Kids will enjoy painting using their creative ideas. You can paint and share it with
your friends instantly. Have fun using paint easy!!!! One of the best free Painting tool!! Children learning to draw, learn the basic colors.
Scribblify Paint Draw & Doodle
Let your creativity run wild with Scribblify, a one-of-a-kind universal drawing and painting tool for children and adults of all ages. From natural to abstract and everything in between, Scribblify allows anyone to create spectacular artwork with ease—limited only by one's imagination. This is a completely free (ad-supported) and full-featured app.
Scribblify is packed with 28 hand crafted brushes, each with its own unique appearance and behavior. From neon glow to glitter, organic to surreal, most of the brushes are unlike anything seen before. The wide variety of exclusive brushes, preset backgrounds, advanced color effects and mirror drawing capabilities ensures endless entertainment for all.
Scribblify is a universal app that works across virtually all Android phones and tablets. Scribblify uses the entire screen as its canvas, so you can create even higher resolution artwork on modern tablets. Free and premium versions of Scribblify are also available for all iOS devices.
○ Paint using 28 original brushes to create endlessly fascinating compositions
○ Choose from 560 brilliant base colors and create custom blends using a variety of innovative effects
○ Select from 28 distinct background textures (55 if inverted)
○ Effortlessly create symmetrical artwork using the horizontal, vertical and quad mirroring system; an option also exists to mirror from wherever you touch for expanded effects
○ Enable plasma, multicolor, color variance and two color blend other effects to produce new styles and textures
○ Easily export your artwork to any compatible app on your device including social network apps and third party illustration tools
Video tutorials and help documentation is available on the official Scribblify website. Please contact support for any assistance.
Note: This is an early version of Scribblify for Android. The iOS version is much more mature with additional brushes and capabilities.
Xbox One SmartGlass
In the living room:
Navigate your Xbox One console using your device's keyboard and touch
Control your media and set top box with the SmartGlass remote control
Browse the web on your TV using your mobile device
Enhance what you are watching or playing with SmartGlass companions
Increase performance with faster connections and reliability
In the living room and on the go:
Search, browse, and pin content to play on your Xbox One console
Track achievements, get game help, message friends, and watch game DVR clips
This app requires an Xbox membership to sign in. Available for most Android 4.0+ smartphones, with WVGA screen resolution or higher, plus 7"" and 10"" Tablets "
Talking Pierre the Parrot Free
Download Talking Pierre's FREE and FUN app and enjoy yourself! He repeats, makes up his own sentences and more!
The genuine bonafide talking parrot has many tricks up his sleeve and he's ready to have all the fun in the world with you! He repeats after you and makes up new sentences, he rocks it out like a true guitar hero and he dodges those tomatoes like a pro!
Enhance the fun by getting the FULL Talking Pierre app which is filled with new animations and responses!
Talk to Pierre: He repeats and invents his own sentences!
Play with Pierre: Try hitting him with a tomato, listen to him rock out on his guitar and have him throw cutlery at you!
Interact with Pierre: Rub his belly, poke him or have him jump the way you want him to!
This app is PRIVO certified. The PRIVO safe harbor seal indicates Outfit7 has established COPPA compliant privacy practices to protect your child's personal information. Our apps do not allow younger children to share their information.
This app contains:
- Promotion of Outfit7's products and contextual advertising
- Links that direct customers to our websites and other Outfit7 apps
- Watching videos of Outfit7's animated characters via YouTube integration
- The option to make in-app purchases
Terms of use: http://outfit7.com/eula-android/
Privacy policy: http://outfit7.com/privacy-policy/
Paint Plus
PAINT PLUS++++++ With Lots of Features
Create artistic and fun Drawings/Painting/Editing with Paint Plus.
Paint Plus is a skilled drawing + painting + editing application for your Android device.
You can create very artistic drawings
on your gallery picture, or;
on an empty canvas/screen.
By using rich Painting tool set, brush effects, emoticons, frames, stroke width, color, pictures, text style to create impressive paintings! Express yourself and share your masterpieces with your friends!
★Smooth Finger paint ★
★Unlimited Undo/Redo Stroke ★
★Random color ★
Random color + Finger Paint is loaded by default later you can switch between random and static color ★
★Brush Tool with lots of effects★
Paint+ Normal
Paint+ Emboss
Paint+ Spray
Paint+ Blur Inner-Outer
Paint+ Solid Neon
Paint+ Round Brush
Paint+ Square Brush ★
★Ever Best Color picker with Billions of Color selection ★
Color Picker for:
Background/Drawing Sheet/Canvas color
Drawing/Painting color
Texting color ★
★Load GALLERY IMAGE + Preloaded PHOTO FRAMES + Pre Loaded EMOTICONS ★
You are able to draw/paint on loaded gallery picture, can also insert frame and emoticons on that same paint screen ★
★SAVE your painted/edited picture in separate folder in your phone gallery as JPEG format (Limited) ★
★SET your painted/edited picture directly as your phone WALLPAPER (Limited) ★
★ERASE your painted/edited screen with custom stroke ERASER ★
★CLEAR whole screen ★
i.e. painted /edited with images, text, frames, emoticons, etc. ★
You are able to enter your custom TEXT with custom SIZE and rich FONT selection ★
★ SHARE WITH YOUR FRIENDS (Limited )★
Paint Plus adds special effects to your own photos and shares it with the world!
By Email Facebook Tweeter, and much more. (Social networking Apps required)
Optimized for Phones and Tablets
If you have any suggestion, new feature request, or any complaint about issues then write to mail on email@example.com
Flow Paint
With Flow paint, you can control of brush style, color, brush size, undo, clear etc.
1) More then 6 brush styles.
2) Color can be random or single depends on choice.
3) User can save painting permanently.
4) Undo marker during paint.
5) Wiper option available for clearing paint page.
6) Rubber for erase drawing portion.
7) Brush size can also change
Future Enhancement:
1) You can pick photo from gallery and draw over photo.
2) Share edited photo or your painting to other one.
3) Share image on facebook and whatsapp.
4) We will add more brush style like multi color, sketch brush, multiple line and curve.
More from developer
España Webcam
Útil para comprobar atascos en carreteras, el tráfico en ciertos puntos o el estado del tiempo en ciertos lugares.
Permite guardar en la tarjeta SD una captura de la cámara (en formato JPG).
Actualmente, se cuenta con cámaras de los siguientes lugares:
* Madrid (+500)
* Tenerife (+100)
* Pais Vasco (+100)
* Valencia (+75)
* Barcelona (+50)
* Extremadura (+50)
* Gran Canaria (+50)
* Baleares (+25)
* Sevilla (+25)
* Zaragoza
* Pontevedra
* León
* Cantabria
* Murcia
* Gijón
* Alicante
* Toledo
* Cádiz
* Lleida
* Ciudad Real
* Lanzarote
* Soria
* Málaga
* Burgos
* A Coruña
* Ourense
* Lugo
* Huelva
* Granada
* La Rioja
* Asturias
* Girona
* Santander
* Almería
* Fuerteventura
* La Gomera
* La Palma
* Valladolid
Si quieres añadir alguna webcam que no figura en el listado (o corregir alguna incorrecta), puedes hacerlo aquí:
* Las cámaras están configuradas para actualizarse lo más rápido que permita cada una.
* Algunas cámaras son imágenes fijas, cargan muy lentas o no actualizan más de una vez al día... ¡No puedo hacer nada para que actualicen más rápido! ¡No soy dueño de todas las cámaras de España! ;)
* Si quieres añadir alguna cámara específica, proponla en la dirección web:
* Esta aplicación es la evolución de la anteriormente conocida "Tenerife Webcam".
* Los permisos de Internet y localización se utilizan para la geolocalización de anuncios de publicidad de AdMob.
Elige tu propia aventura
Repositorio: Actualmente, incluye 4 aventuras EPA.
Versión alfa (aún en desarrollo).
Más información sobre el formato .EPA:
Aplicación que muestra el consumo acumulado de nuestro teléfono móvil de contrato (sólo Vodafone España) de particulares o empresas/autónomos.
Separa el consumo en varias columnas donde se encuentra el consumo de llamadas de teléfono (voz), el de mensajes de texto (SMS) y el de conexión a Internet o tarifa de datos (GPRS/3G).
¿Tienes errores o problemas con la aplicación? Informa en esta página para corregirlos:
NOTA: BudaPhone no es una aplicación oficial de Vodafone. Es sólo un interfaz para móviles Android que utiliza el servicio público y gratuito "Mi Vodafone" de la propia web de Vodafone.
Si tienes problemas de conexión y la ayuda (Menú / Acerca de...) no te sirve de nada, puedes enviarme un email o dejar un comentario en http://bit.ly/budaphone e intentaremos solucionarlo.
Tenerife Webcam
Visor de webcams o cámaras web por toda la isla de Tenerife. Útil para comprobar tráfico, estado del tiempo, etc.
Más información:
* 111 cámaras en total.
* 2 cámaras añadidas.
* Muestra más datos.
* Interfaz re-diseñada.
* Descarga optimizada.
* Otros cambios.
DiceBOFH (Computer excuses)
* Better compatibility.
* More excuses
* Funny mode


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Let's get down to business!
Are you in the Dallas real estate market trying to get your home SOLD? Diane's aggressive marketing plan creates excellent property exposure to thousands of qualified buyers that are shopping homes for sale in the Dallas area and surrounding suburbs. She does MORE than simply entering your home into the MLS. Schedule a free in-home consultation, find out what your home is worth, and how Diane can really help it stand out above the rest!

subset: commoncrawl


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UK VIEW: The Australian squad for the Ashes has been named. The English media have had their say. It's fair to say they're quaking in their boots.
BOXING legend Muhammad Ali has revealed who he will be supporting in next month's Manny Pacquiao vs Floyd Mayweather super fight.
TOTTENHAM winger Andros Townsend came off the bench to steal the limelight from club-mate Harry Kane with a late leveller in a 1-1 draw against Italy in Turin.
DEFENDING champion Mick Fanning has been pitched into a sudden-death round-two encounter at the Rip Curl Pro after finishing a close second in his heat.
THIS is what it is like to play golf with Michael Jordan; if you're good, and can sustain the trash talk, there is lots of money to be made.
Oct 31 - Nov 3, 2014
Event: Sheffield Shield
Teams: Victoria v New South Wales
Date: Friday October 31 - Monday November 3, 2014
Gate opening times
Public/AFL members: 10.00am (Gate 3)
MCC members: 10.00am (Gate 2)
Schedule of Play
Session 1 10.30am - 12.30pm
Interval 12.30pm - 1.00pm
Session 2 1.00pm - 3.00pm
Interval 3.00pm - 3.30pm
Session 3 3.30pm - 5.30pm
Car park opening time
Gate 3 - 9.00am
National Sports Museum: Open from 10.00am until 5.00pm, inside Gate 3.
MCC members
Visitor tickets will only be available to purchase on the day of the event. They cost $6 (adults) and $2 (children). A maximum of four visitor tickets per member applies.
Public tickets
Public tickets will only be available to purchase on the day of the event. Tickets cost $5 (Adults), $2 (Children and Concession) or $12 (Family - two adults and two children).


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Once the wind has been broken, it cannot be fixed.
Electrical tape rules!
How do you guys sanitize the chiller? Been thinkning of makingone of these very soon. Trying to streamline my brewing practices.
I now use 1/2" id 5/8" od beer line for siphoning my 13 gallon carboys. Nice and fast. Plus it hooks up to my filter easier.
Any way back to the CPC. Any issues with beer stone etc clogging these things up over time?
I may not be an expert, but I did stay at a Holiday Inn Express........ 6 months ago.http://www.homebrewtalk.com/f39/denn...9/#post1766281http://groups.homebrewtalk.com/Tapro...ook_Repository
I flush mine with water immediately after use (just use a barbed hose adapter) and then run some Star-San through. Before use I do the same thing...seems to work fine.
OK. BTW Cheyco, I was in Calgary a few day ago. Should have asked you where the HB stores are as I can only find diversol sani and dry yeast here. Should have picked up some liquid yeast and starsan or onestep.
Do you just pass the copper tubing through the newly drilled out compression fittings? What makes this water tight? Or is that here Solder/ JB weld comes into play? I've got all the pieces for this, probably make it up in time for my next batch.
Yup, the copper goes through the drilled compression fittings. They still work the same way as they did before, it's just that now instead of the copper butting up against the shoulder inside the fitting it goes right through. Perfectly watertight if you didn't damage the ferrule seat on the fitting.
Thanks for the quick respopnse, I'll get some pictures of mine up in a little bit. Everything went fine, and I learned how compression fittings worked in the process...
Hate to revive an old thread, but after looking at the wort wizard threads popping around, I'm going to build one of these. One problem though...Lowes and the Depot only sell 3/8" copper in 20' lengths for $30! However, I have an old...I mean about 15 years old..immersion chiller that is 3/8" and about 25' long.
Anything special I'd need to do to use it? I'm thinking blow it our with compressed air, then submerge and boil it, then run some star san or PBW through it and let it soak. Would this work ok, or should I opt for new copper?


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John Andrew Fetherston
|John Fetherston
Do you have a photo that could go here? Submit it for this profile by emailing us!
|Candidate for
|Massachusetts House of Representatives Seventh Middlesex District
|Campaign website
|The information about this individual is current as of when his or her last campaign ended. See anything that needs updating? Send a correction to our editors
John Fetherston was a 2012 Republican candidate for Seventh Middlesex District of the Massachusetts House of Representatives.
Campaign themes
Fetherston's website highlights the following campaign themes:[1]
Common Sense Leadership
- Excerpt:"All the decisions I make will be for the greater good of Ashland and Framingham. I am a common sense leader who believes we need to have a plan for the future. Ashland and Framingham need solutions."
Protecting our Communities
- Excerpt:"I have always said, as Selectmen, that my priorities have always been about public safety and children. I will continue that theme as a State Rep."
Building a Better Massachusetts
- Excerpt:"I believe in building a better Massachusetts. I believe in raising community awareness."
Fetherston ran in the 2012 election for Massachusetts House of Representatives Seventh Middlesex District. He was unopposed in the September 6 Republican primary and was defeated by incumbent Tom Sannicandro (D) in the general election, which took place on November 6, 2012.[2][3]
|Massachusetts House of Representatives, Seventh Middlesex District, General Election, 2012
|Vote %
|Tom Sannicandro Incumbent
|John Fetherston
|Total Votes
Fetherston and his wife Wendy have two children.[4]
Recent news
| Know more information about this profile?
Submit a bio
This section displays the most recent stories in a Google news search for the term "John + Fetherston + Massachusetts + Senate"
- All stories may not be relevant to this page due to the nature of the search engine.
- Loading...
External links
- Official campaign website
- Biography from Project Vote Smart
- Legislative profile from Project Vote Smart
- John Fetherston on Facebook
- John Fetherston on YouTube
- ↑ "jonfetherston," Official Campaign Website
- ↑ Massachusetts Secretary of the Commonwealth, "2012 State Primary Results," accessed February 13, 2014
- ↑ Massachusetts Secretary of the Commonwealth, "Return of Votes - For Massachusetts State Election - November 6, 2012," accessed February 13, 2014
- ↑ Project Vote Smart, "Biography," accessed June 2, 2014
State of Massachusetts
Boston (capital)
|Ballot Measures
List of Massachusetts ballot measures | Local measures | School bond issues | Ballot measure laws | Initiative laws | History of I&R | Campaign Finance Requirements | Recall process |
Massachusetts State Constitution | House of Representatives | Senate |
|State executive officers
Governor | Lieutenant Governor | Attorney General | Secretary of State | Treasurer | State Auditor | Commissioner of Education | Commissioner of Insurance | Commissioner of Agriculture | Secretary of Energy and Environmental Affairs | Secretary of Labor and Workforce Development | Chair of Public Utilities |
|School boards
Massachusetts Department of Elementary and Secondary Education | Massachusetts school districts |
Massachusetts Supreme Judicial Court | Appeals Court | Superior Courts | District Courts | Probate and Family Courts | Juvenile Courts | Housing Courts | Land Courts | Boston Municipal Courts | Judicial selection in Massachusetts |
|Transparency Topics
Public Records Act | Open Records procedures | Transparency Advocates | Transparency blogs | State budget | Taxpayer-funded lobbying associations |
State |
List of Counties |
List of Cities |
List of School Districts |


text:
Curaprox: Smile, 2
Swiss premium oral care.
5460 filaments for a perfect smile.
Advertising Agency: Imelda Ogilvy, Ljubljana, Slovenia
Executive Creative Director: Jure Požun
Copywriters: Jure Požun, Luka Šimunovič
Art Director: Branislav Milošević
3 comments
Richa AgrawalNov 09, 2012 - 0:44
why did u need 3 similar ads? just to make it look like a campaign? the ad is nice though.


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Several area sports teams played last night, with boys basketball leading the pack in wins. In boys basketball, Little Falls took home a Granite Ridge Conference (GRC) win 67-40 over Mora. Pierz' boys team won 76-66 over Rockford in a Central Minnesota Conference (CMC) game. Holdingford, howev...Read More
Several sports teams from the area were in action on Friday, Saturday or a combination of both. In boys basketball the Little Falls Flyers played both days, falling 53-40 to Cathedral Friday, and beating Perham 58-47 Saturday. Royalton earned its second win of the season Friday with a 50-42 win over...Read More
By Tyler Ohmann Sports Editor [email protected] Both Pierz and Holdingford's girls basketball teams were on the losing end of Central Minnesota Conference (CMC) games, Jan. 9. The Pioneers lost 61-38 to Eden Valley-Watkins. Brianna Meyer had 15 points, and Talyre Boser added 10, but it was...Read More
Pierz comes out on top after 8-1 record in duals during busy week By Tyler Ohmann Sports Editor [email protected] The wrestling regular season hit its stride for area teams as Little Falls, Holdingford and Pierz all met. And after all the action on the mat, the Pioneers appear to have a stra...Read More
By Tyler Ohmann Sports Editor [email protected] In front of the hometown crowd, the Holdingford Huskers showed that they not only came to play, but that they had a great chance to win in a Central Minnesota Conference (CMC) rivalry against Pierz, Jan. 8. The Huskers took a lead early in the ...Read More
Last night's sports action featured a Central Minnesota Conference (CMC) rivalry between the Pierz and Holdingford girls basketball teams. Both teams entered the game with identical 2-8 overall records and were both winless in conference play. After the game, however it was the Pioneers who ea...Read More
By Tyler Ohmann Sports Editor [email protected] Both Pierz and Holdingford's girls basketball teams dropped their third Central Minnesota Conference (CMC) games Tuesday, as they came back after the holiday break. Pierz fell 70-63 to Howard Lake-Waverly-Winsted (HLWW) in another close loss,...Read More
Athletic events were still running last night, despite the lowering temperatures outside and several schools delaying or closing school today. Wrestling was busy with three of the four area teams competing in duals. Little Falls fell 49-17 as it traveled to St. Cloud Tech. Pierz lost in a close one,...Read More
By Tyler Ohmann Sports Editor [email protected] Upsala's girls basketball team hosted an eight-team tournament Monday and Tuesday. Holdingford was one of those teams, and both the Huskers and Cardinals split their two games in the tournament. Upsala lost 64-62 on a last second effort by Ki...Read More


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World Congress Tissue Engineering and Regenerative Medicine International Society Vienna, Austria September 5-8, 2012 Industry Day Symposium SESSION 2: "The Regulatory Imperative: International Perspective" Organized by TERMIS-AM and TERMIS-EU Industry Committees Concept/Discovery Research to Successful Product Public/Private Funding Discovery Clinical Trials Market Successful Product Research Intellectual Property Regulatory Evaluation Public(s) Perception & Patent Protection & Product Approval & Market Acceptance SCIENCE Talent/People 2 TERMIS-EU Industry Committee • Established 2011 • Mission – Motivate translation of academic research into commercial products, in Tissue Engineering/Regenerative Medicine (TE/RM) – Connect the scientific & clinical communities with TE/RM industries • Goals – Give answers to critical questions, paving the road of TE/RM commercial translation, by key stakeholders, from past experiences – Promote academia–industry meetings & partnerships for more effective commercial translation in TE/RM • Members – Yves Bayon, PhD; Covidien – Sofradim Production; Chair – Simon Ellison, MBA; NHS Blood & Transplant – John Barry, PhD; Baxter Innovations – Paul Stroemer, PhD, Reneuron – Chris Mason, PhD; University College of London 3 – Alain Vertes, PhD; London Business School Sloan Fellow TERMIS-AM Industry Committee • Established 2009 • Mission – Support commercialization in Tissue Engineering/Regenerative Medicine (TE/RM) • Goals – Define and address obstacles/hurdles to product commercialization – Promote collaborations to build a viable TE/RM industry • Members – Kiki B. Hellman, PhD; The Hellman Group. LLC; Chair – Timothy A. Bertram, DVM, PhD; Tengion – Peter C. Johnson, MD; Avery Dennison – Mark Van Dyke, PhD; Wake Forest University Health Sciences – Bill Tawil, PhD; Baxter Biosurgery 4 TERMIS-AM Industry Committee 'Commercialization Hurdles' 2010 – First Annual Industry Committee Symposium* • Survey of TERMIS-AM membership on perceived hurdles to commercialization of TE/RM products • Most common hurdles identified by academe, and start- up, development stage, established companies – Funding – Regulatory pathway – IP and technology transfer ----- *Publications: 1. "Hurdles in Tissue Engineering/Regenerative Medicine Commercialization: A Survey of North American Academe and Industry," Tissue Engineering, January 2011. 2. "Challenges in Tissue Engineering and Regenerative Medicine Product Commercialization: Building an Industry," Tissue Engineering, January 2011. 5 TERMIS-AM Industry Committee 'Funding' 2011 – Second Annual Symposium* • Survey of financial community (public, private, government) • Key Findings – Investment interest >60% – Perceived challenges for investment • Regulatory pathway clarity • Clinical translation --- Publication: "Hurdles in Tissue Engineering/Regenerative Medicine Commercialization: A Survey of the Financial Industry," Tissue Engineering, November 2012 (in press). 6 The Regulatory Imperative: International Perspective TERMIS-NA Industry Committee Surveys Regulatory pathway a major hurdle Regulatory clarity and predictability – key for commercialization and industrial development 7 The Regulatory Imperative: International Perspective Regulatory Framework Principles and requirements governing assessment of regenerative products, i.e., review and marketing approval Globalization Challenges for regulatory authorities due to the global R&D effort in TE/RM outside their purview, i.e., outside US and EU Regulatory Harmonization Development of a common dialogue and approach among regulatory authorities leading to congruence of national practices and consensus on regulatory requirements, i.e., a unified regulatory strategy 8 Symposium Participants Presentations Lucia D'Apote, PhD; European Medicines Agency (EMEA), United Kingdom Celia Witten, MD, PhD; Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), United States Panel Tim Bertram, DVM, PhD; Tengion, Inc., USA Maria Pascual-Martinez, PhD; TiGenix Alison Wilson; Cell Data Services Leslie Wolfe, PhD; Genzyme Chair Kiki B. Hellman, PhD; The Hellman Group, LLC, USA Summary Tim Bertram, DVM, PhD; Tengion, Inc., USA 9 European Regulatory environment of regenerative medicine TERMIS Industry Symposium 7 September 2012, Vienna (Austria) Presented by: Lucia D'Apote, PhD An agency of the European Union European Medicines Agency Overview The EMA CAT and the RegMed pipeline in Europe Regulatory path and regulatory requirements Specificities and Challenges International Cooperation (EMA-FDA) 11 Lucia D'Apote - EMA The EMA CAT and the RegMed pipeline in Europe 12 Lucia D'Apote - EMA Established in 1993, operational since 1995 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Tel:+44 (0) 20 7418 8400 Fax: +44 (0) 20 7418 8416 13 Lucia D'Apote - EMA www.ema.europa.eu The ATMP Regulation Committee for Advanced Therapy New Scientific Arena Expertise Beyond Traditional Research 14 Lucia D'Apote - EMA ATMP Pipeline – what we see 15 Lucia D'Apote - EMA Objective : Facilitate development of ATMPs and access to MA procedure ► understand trends in research and development, with a view to planning CAT workload and resources accordingly http://www.ema.europa.eu/doc s/en_GB/document_library/Wor k_programme/2010/11/WC500 16 099029.pdf ATMP Pipeline – what we will see ► 318 clinical trials from EudraCT (1 May 2004 - 31 December 2010) ► 244 national = more than 70% ► 74 multinational = less than 30% 17 Lucia D'Apote - EMA Products Based on self-classification: ► GTMPs + sCTMPs + TEPs: 250 ► GTMPs =54 = 22% ► sCTMP/TEPs= 196 = 78% ► phase I and II or I/II: 81% ► phase III/IV:19% ► phase IV, as assigned in the database: 7 CT 18 Sponsors: who ► Who is conducting the CT with ATMPs in Europe? 173 sponsors 104=60% Academia/hospitals, 69=40% Industry (including SMEs) 4% big pharma 24% SMEs 72% other (non registered SMEs) 19 Sponsors: from where ► 19 countries in total ► 15 EU/EFTA Countries (SP, DE, UK, NL, FR, BE) ► 4 non-EU/ EFTA region (US, Israel, Switzerland, Canada) ► almost all academia/charity sponsors situated in Europe ► some commercial sponsors (24/69 or 34%) situated outside Europe 20 Therapeutic areas majority of CT in solid tumours (67 products), followed by the cardiovascular area (48 products), and haematology including haematological malignancies (33 products) 21 Lucia D'Apote - EMA Orphan ATMPs 26 CT with Orphan ATMPs Mainly commercial sponsors Majority with cell- based products 75 ODD so far are ATMPs !!! 22 Lucia D'Apote - EMA Regulatory path and regulatory requirements 23 Lucia D'Apote - EMA EU Marketing Authorisation (MA) for ATMPs A medicinal product may only be placed on the market in the EU, when a marketing authorisation has been issued by the European Commission (via the Centralised Procedure – EMA) or it is regulated by the competent authority of a EU Member State (hospital exemption) 24 EMA - Lucia D'APOTE 24 25 Lucia D'Apote - EMA Risk based approach 26 Lucia D'Apote - EMA Risk-management plan and follow-up safety/efficacy 27 Lucia D'Apote - EMA Same evaluation, different MA? • Conditional approval vs Exceptional circumstances - to meet unmet medical needs of patients and in the interest of public health 28 Lucia D'Apote - EMA Accellerated assessment 150 days - in order to meet, in particular the legitimate expectations of patients and to take account of the increasingly rapid progress of science and therapies, for medicinal products of major interest from the point of view of public health and in particular from the view point of therapeutic innovation. - There is no single definition of what constitutes major public health interest. This should be justified by the applicant on a case-by-case basis. 29 Lucia D'Apote - EMA Specificities and Challenges 30 Lucia D'Apote - EMA ATMP Translation: perceived challenges Gene and Cell based products are complex Market (specific and small) Lack of funds and costly investments Regulatory barriers 31 Lucia D'Apote - EMA Challenges with ATMPs: examples • Scientific challenges – Manufacturing constraints & quality issues – Non-clinical challenges – Clinical challenges Disclaimer: ATMPs are a very diverse group of products, so the challenges listed in the next slides are only examples! 32 Quality/manufacturing issues - Control of all starting and raw materials - Human cells/tissues + any human/animal reagents (e.g serum) - Recombinant growth factors - History of cell-lines / vector constructs - Appropriate characterisation and product testing (including potency assay*) - Poor definition and control of a product may directly effect safety & efficacy - Good control of the product is essential for manufacturing changes (e.g. product upscale) - Manufacture in GMP environment * Potency assay: product specific, at least semi-quantitative, linking product testing with clinical effect 33 /biological activity Non-clinical challenges – What animal models to be used to test a human cell-based therapy or gene therapy product? – Use of a homologous model? / Disease models?/ Other relevant animal models? – Proof of concept studies / toxicity studies – Dose finding studies? – Bio-distribution studies? – Germ line transmission for GTMP – Environmental risk / Shedding studies for GTMP 34 Clinical challenges – Dose finding studies – How to find the most effective dose, e.g. for a TEP? – Design of clinical trial – What is a suitable compatitor? – Blinding might be very difficult – Endpoints for TEP (how to measure structure repair?) – Effect of concomitment treatment / surgery on Efficacy & Safety? – Long term efficacy and safety follow-up studies 35 Challenges with ATMPs • Scientific challenges – Yes! • But not all challenges are scientific! – Regulatory issues – Lack of regulatory expertise – Resources – Reimbursement issues – Competition with 'hospital exempted ATMPs' 36 Prospective product development Courtesy of dr. Paula Salmikangas, 2012 37 Lucia D'Apote - EMA Retrospective product development Courtesy of dr. Paula Salmikangas, 2012 38 Lucia D'Apote - EMA The way forward Raise awareness – strengthen dialogue Learn from experience 39 Lucia D'Apote - EMA Nature Reviews Drug Discovery, vol 9, March 2010, 185-201 Regulatory Rapporteur, vol 8, July-August 2011, 4-7 40 Advice during development 41 Lucia D'Apote - EMA Regulatory strategy: save time Scientific advice: Complying with SA/PA is significantly associated with positive outcome Positive MAA outcome related to compliance with SA/PA received 100% 90% 97% 80% 70% 38/39 72% 60% 50% 93/129 40% 30% 30% 20% 10% 6/20 0% Compliant with SA Non-compliant with SA No SA received received Regnstrom J, Koenig F, Aronsson B, et al. (2010) Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency; EJCP 66:39-48 42 Lucia D'Apote - EMA 43 Lucia D'Apote - EMA 44 Lucia D'Apote - EMA International Cooperation (EMA-FDA) FDA-EMA-HC ATMP Cluster ICH Regulators Forum Cell Therapy Group Parallel Scientific advice http://www.ema.europa.eu/docs/en_GB/document_libra ry/Other/2009/11/WC500014868.pdf 45 Lucia D'Apote - EMA Parallel Advice FDA Confidentiality Agreement FDA Applicant to address request to both Agencies Agreement principles since 2004 pilot Applicant initiative- exceptionally Agency initiative 46 Procedure Parallel Advice Initial discussion both Agencies Prime candidates-breakthrough products – no GL exist or GLs differ between Agencies Submit request in usual manner Timetable agreed between Agencies Tele-video-conference about D60 47 Outcome No applicant involvement in draft reports Parallel separate advice given not 'joint' advice Confidentiality maintained Standard fee applies 48 Thank you for your attention! Lucia D'APOTE European Medicines Agency (EMA) firstname.lastname@example.com 49 Lucia D'Apote - EMA Regulatory and Scientific Experience in Regenerative Medicine in OCTGT Termis Industry Symposium Vienna, Austria September 7, 2012 Celia M. Witten, PhD, MD Office Director Office of Cellular, Tissue, and Gene Therapies Center for Biologics Evaluation and Research United States Food and Drug Administration Outline • FDA Mission & Organization • OCTGT Activities • Special Programs 2 51 FDA Mission Statement The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. 52 3 FDA Organization • CBER (Center for Biologics Evaluation and Research): vaccines, blood and blood products, human tissue/tissue products for transplantation, cells, gene therapy – Office of Cellular, Tissue, and Gene Therapies – Office of Vaccines Research and Review Product Offices – Office of Blood Research and Review • CDER (Center for Drug Evaluation and Research): drugs, some biological products • CDRH (Center for Devices and Radiological Health): devices for treatment, implants, diagnostic devices • CVM • CFSAN • NCTR • CTP • ORA • OC 4 OCTGT Activities • Regulatory review • Policy and regulatory guidance development • International Activities and Standards • Outreach – Advisory Committees – Talks, workshops – Seminars, panel discussions, round table • Publications • Mission-related Research 5 New IND and IDEs Submitted to OCTGT: Commercial or Research Sponsors 140 120 100 80 commercial 60 research 40 20 0 2003 2004 2005 2006 2007 2008 2009 2010 2011 6 Examples of OCTGT Products • Stem cell and stem cell-derived products – Hematopoietic, mesenchymal, cord blood, embryonic, iPSc, etc • Somatic cell therapies – Pancreatic islets, chondrocytes, myoblasts, keratinocytes, hepatocytes • Gene therapies – Genetically modified cells – Plasmids, viral vectors, bacterial vectors • Therapeutic vaccines and other antigen-specific active immunotherapies – Cancer vaccines and immunotherapies, such as dendritic cells, lymphocyte-based therapies, cancer cell-based therapies, peptides, proteins – Non-infectious disease therapeutic vaccines, such as peptides, proteins, small molecules • Devices and combination products – Devices with a cellular component – Selected devices for the manufacture or delivery of cells 7 Regulatory Review 8 FDA Medical Product Regulatory Paradigms are Tiered • Risks Inherent to the Product • Manufacturing Complexity • Clinical Uses • Other Differences Leads to Tiered Review Requirements 9 Two General Classes of FDA-Regulated Medical Products • No Premarket Review – Some Human Tissues (361 HCT/Ps) – Some Devices (exempt 510(k)) – Some Drugs (monograph) • Premarket Review/notification – 510(K) Devices (non-exempt) – PMA Devices – BLA- Biologic Drugs – NDA- Drugs 10 Starting Point for FDA Interaction • Guidance in specific investigational areas – Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage – Somatic Cell Therapy for Cardiac Disease • General guidances to support specific areas of tissue engineered medical products – CMC guidances for cellular and gene therapy products – General preclinical guidances – Guidances for scaffolds and devices – General clinical guidances • Standards from SDOs (ASTM, ICH, ISO, USP...) • Pre-submission meeting with appropriate FDA Center/office 11 Policy & Regulatory Guidance Development 12 Recent CBER Guidances Guidance for Industry: Cellular Therapy for Cardiac Disease (Oct 2010) Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products (Jan 2011) Guidance for Industry: INDs for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications (June 2011) Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines (Oct 2011) Current Good Tissue Practices (CGTPs) for Manufacturers of Human Cells, Tissue and Cellular and Tissue-Based Products (HCT/Ps) (Dec 2011) Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (Dec 2011) 13 FY 2012 Program Priorities Guidance for Industry: Draft – Preclinical Safety Assessment of Investigational Cellular and Gene Therapy Products 14 Recent CTGTAC Advisory Committee Topics Testing for Replication Competent Retrovirus (RCR) Lentivirus (RCL) in Retroviral and Lentiviral Vector Based Gene Therapy Trials – November 2010 Cell and Gene Therapy Trials in Retinal Disease – June 2011 New York Blood Center BLA for umbilical cord blood - September 2011 Miltenyi Biotec HDE for CliniMACS CD34 Selection System – September 2011 Organogenesis BLA for the treatment of surgically created gingival and alveolar mucosal surface defects in adults – November 2011 15 International Activities and Standards 16 FDA's Goals for International Collaborations • To safeguard global public health, • To assure that consumer protection standards and requirements are met, • To facilitate the availability of safe and effective products, • To develop and utilize product standards and other requirements more effectively • To minimize or eliminate inconsistent standards internationally. 17 FDA-European Medicines Agency (EMA)- Health Canada (HC) ATMP Cluster • Regular teleconferences to share thinking on regulatory approaches on both general and specific issues • Share draft documents for comments • Engage reciprocally in workshops advisory committees, and working parties 18 Asia Pacific Economic Cooperation-Life Sciences Innovation Forum (APEC/LSIF) • 13 countries participated • Goal: To bring together a group of stem cell leaders from corporate, academic, and government sectors to discuss and further develop a regulatory frame work for QA/QC for stem cell products • Information Gathering Opportunities – Regulatory landscape for cell therapies – Guidance documents in place or under development for (stem) cell therapies – (Stem) cell therapy products in clinical trials or already licensed • Outcomes: Regulatory gaps for stem cell products exist among the participating countries 19 Regulators Forum Cell Therapy Group • Goal: Identify areas of possible areas for convergence/harmonization • Why convergence/harmonization for cell therapy products? • Cell therapy is an emerging product class posing substantial regulatory challenges • Regulatory frameworks are in different states of maturity internationally • Limited experience in reviewing marketing applications for cell therapy products • ICH & non-ICH product guidelines not directly applicable to CT products • Harmonization of technical requirements useful tool to strengthen the safe and effective use of cell (stem)- based products 20 Regulations vs. Standards • Regulations – Government implementation of statues that have the force of law – Define specific requirements for safety – Provide accurate information to health professionals and consumers • Standards – Voluntary – Frequently developed outside of the government – Written standards describe how manufacturers might meet regulatory requirements – Physical standards provide accepted "benchmark" materials 21 Use of Consensus Standards by Federal Agencies • Mandated by PL 104-113 National Technology Transfer and Advancement Act of 1995 • Interpreted by OMB Circular No. A119 http://www.whitehouse.gov/omb/circulars_a119_a119fr • Standards and Global Harmonization 22 Impact of Guidance and Standards • SDOs can sometimes produce documents or physical standards more quickly than FDA can produce Guidance documents • Effort can be shared with non-FDA experts • SDOs can cover areas that are difficult to put in FDA Guidance – Specific (proprietary) methods for tests or processes – Critical reviews of emerging fields 23 Use of Standards in CBER • Use in Review of Applications – Sponsor cites standard in meeting or application • ISO 10993.xx (Biocompatibility) • ATCC VR-1516 (Adenovirus Type 5 Reference Material) – Use as Information Resource • ASTM 2451-05 – Standard Guide for in vivo assessment of implantable devices intended to repair or regenerate articular cartilage • ANSI/AAMIISO 7198 Cardiovascular Implants: Vascular Graft Prostheses 24 International Clinical Trials • Acceptance of studies in support of an IND or marketing application – If conducted under an IND all requirements must be met unless waived – If not conducted under an IND must meet 21CFR312.120, which addresses good clinical practice issues, ability to validate data from onsite inspection if necessary, supporting information, etc. 25 International Clinical Trials • Acceptance of foreign data as sole basis for marketing approval is governed by 21CFR312.120 – Applicability of data to u.s. population and medical practice – Studies performed by clinical investigators of recognized competence – Data valid without an onsite inspection or FDA can perform on-site inspection to validate data 26 Special Programs 27 Fast Track, Accelerated Approval, and Priority Review • These terms apply to licensure or to the licensure process for drugs and biologics • Fast Track: process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need • Accelerated Approval: allows earlier approval of drugs to treat serious diseases, and that fill an unmet medical need based on a surrogate endpoint. A confirmatory trial is needed. • Priority Review: Two tiered system of review times – Standard Review: ten month time frame – Priority Review: six month time frame. Designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. 28 Expanding Access to Investigational Drugs • Use of an investigational drug outside of a clinical trial, for the sole purpose of treating a patient or patients with a serious or life- threatening disease who have no acceptable medical options • Levels of expanded access are based on the number of patients to be treated and how much is already known about the drug: – Individual or intermediate size group access – Treatment IND 29 Orphan Drug and Humanitarian Device Designation • Orphan Drug Designation: orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug – This does not alter the standard regulatory requirements and process for obtaining marketing approval • Humanitarian Use Device: designates a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year – HDE exemption 30 Food and Drug Administration Safety and Innovation Act (FDASIA) • Signed into law July 9, 2012 • Fifth reauthorization of PDUFA • Sec 902- Breakthrough Therapies – Criteria for "Breakthrough Therapy" Designation – Potential agency actions to expedite review of designated drugs – Guidance document on implementation by 18 months 31 OCTGT Regulatory Resources • OCTGT Learn Webinar Series: http://www.fda.gov/BiologicsBloodVaccine s/NewsEvents/ucm232821.htm • Regulatory Questions: firstname.lastname@example.com Patrick Riggins, Ph.D. – (301)827-6536 32 81 Public Access to CBER CBER website: http://www.fda.gov/BiologicsBloodVaccines/default.htm Phone: 1-800-835-4709 or 301-827-1800 Consumer Affairs Branch (CAB) Email: firstname.lastname@example.com Phone: 301-827-3821 Manufacturers Assistance and Technical Training Branch (MATTB) Email: firstname.lastname@example.com Phone: 301-827-4081 Follow us on Twitter https://www.twitter.com/fdacber 33 Contact Information Celia Witten, Ph.D., M.D. Office Director, OCTGT CBER/FDA 1401 Rockville Pike (HFM-700) Rockville, MD 20852-1448 301-827-4163 email@example.com 34 Panel Discussion Question #1 – Since product development, including clinical studies in TE/RM is now a global enterprise, what CMC, clinical, and pharmacology/toxicology aspects of international studies may be acceptable to both EMEA and FDA? – What criteria will form the basis for regulatory decision-making in product approval? 84 Panel Discussion Question #2 – What priorities do the FDA and EMEA foresee in developing 'best practices' for regenerative products, i.e., clinical trial design, manufacturing processes and release criteria, among others? – How can 'best practices' from various regulatory agencies be developed and adopted to accommodate reciprocity across national boundaries? – What industrial-regulatory mechanisms are the most effective in establishing a cooperative dialogue with FDA and EMEA regarding such issues? 85 Panel Discussion Question #3 The FDA and EMEA have different legislated product approval pathways permitting accelerated or expedited product approval. – What criteria would form the basis for accelerated or expedited product review of a TE/RM product? – Would any other means of rapid product approval for TE/RM products be considered as long as patient safety is demonstrated? 86 Regulatory Imperative Session Summary • Regulatory barriers are considered as major challenges for TE/RM product commercialization - academics, industrialists, financiers, and regulators. • Both FDA and EMA have recognized the regulatory challenges presented by TE/RM product technologies, raw materials, pre- clinical testing, and clinical assessment. • TE/RM product pipeline is broad and deep presenting unique challenges for regulators such that the EMA CAT and FDA Pre- Submission Meetings allow sponsors to obtain specific guidance on their respective technology (cells, genes, combinations, etc). • TE/RM products are complex presenting unique manufacturing, pre- /non-clinical and clinical challenges for regulation 87 Regulatory Imperative Session Summary • Both EMA and FDA: – Take a risk-based/tiered approaches to evaluate the specific risks unique to each TE/RM product submission. – Have identified special pathways (e.g. orphan, accelerated assessments, etc) to encourage TE/RM therapies reaching the market most expeditiously and are safe and effective for the intended patient population. – Promote long-term follow-up on safety, efficacy and durability of TE/RM products – Have entered into agreement for parallel advice and collaborations with industrial organizations on regulation of TE/RM product development – Offer specific guidance to industry in key technological areas of concern: scientific advise being sought by sponsors has focused on non-clinical challenges although clinical trial design have also served as a topic of industrial interest. – Accept international studies for marketing applications if they meet specific requirements for data validity, good clinical practices and supporting information 88 Regulatory Imperative Session Summary • The way forward for TE/RM technologies and products includes: – Raise awareness of unique safety challenges and efficacy opportunities – Learn from experience as these new technologies advance to commercialization and become standards of care. – Promoting industrial-regulatory and regulatory-regulatory dialog to promote the commercialization of safe and effective TE/RM technologies for unmet medical needs 89 A copy of the slides for Session 2 will be available online via the TERMIS website, www.termis.org. 90
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Robert Atkinson contributed the chapter "Innovation in Cities and Innovation by Cities" for the book "Creating Competitiveness: Entrepreneurship and Innovation Polices for Growth."
In a chapter for the new book Practicing Sustainability, Rob Atkinson wrote about sustainability from an innovation economics perspective.
"Innovation Economics: The Race for Global Advantage." This new book delivers a critical wake-up call: a fierce global race for innovation advantage is under way and the United States is running the risk of losing.
Daniel Castro contributed a chapter titled "U.S. Federal Cybersecurity Policy" in the book "Cybersecurity: Public Sector Threats and Responses."
Rob Atkinson contributed a chapter titled chapter "Who's Who in Internet Politics" for the book "The Next Digital Decade: Essays on the Future of the Internet."
Supply-Side Follies: Why Conservative Economics Fails, Liberal Economics Falters, and Innovation Economics is the Answer
Supply-Side Follies methodically debunks the common assumptions of conservative economics and demonstrates why it is a flawed doctrine that is setting up the U.S. for a major economic downturn in the near future.
Taking into account the historical record, the book discusses the shortcomings of prevailing liberal and conservative economic doctrines and lays out a new growth economics agenda aimed at maximizing the productivity and innovation-enhancing forces of the New Economy.


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Justin Timberlake + Jessica Biel Share First Wedding Photo
Time for a peek into the wedding album of Justin Timberlake and Jessica Biel. And wait till you see the dress. Oh, the dress.
Time for a peek into the wedding album of Justin Timberlake and Jessica Biel. And wait till you see the dress. Oh, the dress.
All it took was getting married for Justin Timberlake to go public (finally!) with some new music. The singer, who has not released an album since 2006's 'FutureSex/LoveSounds,' sang a new love song for his wife Jessica Biel at their wedding in Italy last week.
Justin Timberlake is slick! The 'SexyBack' singer wed Jessica Biel on Oct. 19 in Italy. While their guests knew they were going to a wedding, when they boarded a private jet chartered by the singer, they didn't actually know where the wedding was taking place.
We knew it was likely to happen this weekend, but apparently Justin Timberlake and Jessica Biel think Saturday weddings are trite -- because word just came down that the two already tied the knot in Italy.
Justin Timberlake and fiancée Jessica Biel might make it official this week -- and in Italy, of all romantic locales. The long-engaged couple, who decided to unite in marriage over the holidays in 2011, are reportedly set to tie the knot this week.
Justin Timberlake and Jessica Biel are reportedly saying arrivederci to single life this weekend -- and tying the knot in Italy.
Justin Timberlake has been relatively quiet about his personal life (post-Britney Spears, especially). Though he and fiancee Jessica Biel are a pretty private couple by Hollywood standards, but he's opening up about how they met, got together and eventually how they'll deal with married life.
Justin Timberlake continues to grab more movie roles, leaving his music career simmering (getting cold even?) on the backburner. The MySpace investor is deep in discussions to star in 'The Last Drop,' a new dramedy.
Justin Timberlake is an investor in the flailing, former social media giant known as MySpace. Yes, MySpace still exists, although we wouldn't say it's going strong! He and the the new owners recently unveiled the site's redesign, which looks strikingly similar to Pinterest. While MySpace has fallen from its former digital glory, Timberlake is part of a team that hopes to restore the platform to prominence.
Remember back in 2005 when Myspace was cool? We blogged about our crush from middle school science class, took those "what would you do if..." surveys, and felt honored when we made it into someone's "top friends" box. Those were the days.


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Video | August 14, 2007
Rotary unit fills/seals pouches of Pocket Shot liquorVideo of the filling and sealing of 50-mL premade pouches of Pocket Shot done at 20-25 packs/min on an 8-station rotary machine.
To read the Pocket Shot article, click here.
The machine, a Model FBM-10 filler/sealer from Laudenberg (www.laudenberg.com) of Germany, has been installed at the contract packager, Frank-Lin Distillers Products Ltd. (www.frank-lin.com/services.html).
To read the Pocket Shot article, click here.
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THE INDEPENDENT BOOK GROUP: A love story, for crying out loud
A science-fiction novel reduced our book group members to tears. CHRISTINA PATTERSON reports on an emotional month
Christina Patterson
Christina Patterson is a writer, broadcaster and columnist. She writes about politics, society, culture, travel, books and the arts. She has interviewed writers and artists ranging from Martin Amis to Eddie Izzard and Werner Herzog, and did the first interview after he left office with Gordon Brown. A former director of the Poetry Society, and literary programmer at the Southbank Centre, she has written for the Observer, the Sunday Times, the Guardian, Time, the Spectator and the New Statesman. She's a regular commentator on radio and TV news programmes, a regular reviewer on the Sky News press preview, and a regular guest on The Review Show. She has campaigned to improve standards in nursing in a series of articles in the Independent, by speaking at conferences, and in programmes she has made for Radio 4 and The One Show. Christina is the only woman on the shortlist for the Orwell Prize 2013. She has now left The Independent, but can be contacted via her website, www.christinapatterson.co.uk .
Friday 04 February 2005
Well, this month, at any rate, it was something like that. Da Vinci-induced vitriol vanished in favour of a marvellous new commodity: enthusiasm. mrsboggart, opening the proceedings, set the tone. "I read this book about eight months ago" she announced. "After a slow start I remember being really gripped by it". She was"looking forward to reading it again". Mo245 was "just over half way through, and loving it." She was finding it "incredibly readable" and "fascinating" and thought the characterisations were "remarkably good". Confusingly for a book about time travel, she had a copy that jumped straight from page 186 to 235. Was this deliberate or an error?
An error, thought mrsboggart, who helpfully filled in the missing scene. She felt excited, she confided, just "remembering how beautiful and clever it is. The time travel device is just so well executed". Mo245 decided that she could "read around" the error for now and posted a message telling everyone that this was "an amazing book, in that rare category of books which are so well written that other books are shown up to be simply a flickering shadow". It had also, she said, made her cry - the "first time from a book". Jerry Springer, eat your heart out. Our book group is a much better place for embarrassing confessions.
Even Shirley from Sussex, a book group stalwart who has struggled to find the finer points in some of our choices, appeared to be hooked. "I don't know what it is about this book that's gripping me" she declared "but something is!" Although "nothing particularly remarkable" was happening, she thought it was "really good. Audrey" she added chummily "has a very good imagination".
Netty121 was also "thoroughly enjoying it", but had, at last, identified a jarring note. Unfortunately, it was just the cover. She "found the image of the small girl, alongside a grown man's shoes a little disturbing", conjuring up ideas that "do not at all reflect the beauty of the prose". Mo245 didn't like the cover either, but jellyfeeble hadn't noticed it. She'd just "picked up the book and started to read". She, too, was enjoying it so far, but she was also a bit worried about Henry's employment record. "When does Henry have time to work" she wondered "if all he seems to be doing is time travelling?" That's the spirit, jellyfeeble. Come and work here! The management would love you. More importantly, perhaps, she was worried that Henry had beaten up another character with "apparent enjoyment". mrsboggart leapt to his defence. "I think if I was Henry" she declared "I would have done the same thing".
Mehari was "only slightly alarmed by Henry's other skills in criminal directions". He was "fascinated" by the novel's "gentle humour and invention", but annoyed to find that Julian Clary had given away the plot on Richard & Judy. Luckily, he'd only videoed it, but his partner had watched and "come away fuming".
PhilDeans, a relative newcomer to the group, joined the swelling fan club. He'd picked the book up at an airport before Christmas, thought it looked "a bit Chick lit" and put it back down. "Just shows how wrong you can be" he added darkly. "The last chapters were so emotional" he confided "that when I had finished I just had to play a Nick Cave CD to capture the mood completely. The new one" he continued helpfully "is perfect". He was, however, a bit worried about the author's attitude to men. All the male characters, he thought "were slightly or completely disfunctional in some way: alcoholic, violent, cheating on their partner, leaving without reason then coming back without explanation". A searingly accurate portrayal of the sex, then. He was particularly worried about "the habit of running around naked which let's be honest most guys have a tendency to do".
Shirley didn't comment on naked guys, but she was ready to pronounce. "An excellent read" she declared - the Shirley equivalent, perhaps, of a Nobel Prize. LJ2026, a new participant and a self-confessed online forum virgin, was equally enthusiastic. It was, he said, "one of the most compelling books" he had read in a long time, one which had him "blubbering" into his tea. Mo245 was too busy worrying about free will to weep. "If past events could not be changed, then do we have free will?" she asked. Mind you, "delving too deeply would probably have ruined an excellent story".
And then, at long last, a dissenting voice appeared. "Found it a bit `chick lit' and lightweight" said the pithily named zig. "Sorry". He had liked Henry's character, and his choice of music, but found Clare "too good to be true". It got, he thought, "very `mills and boon' at the end." OliviaDW profoundly disagreed. The book, she said, "was a first for me - first to make me cry, first to make we want to go and hear the author speak about her book, and first to spur me to write my comments on an internet book club!" Three confessions of tears in one month! In journalistic terms, that's a trend.
Meanwhile, 2wabbits had finally broken his silence. He was "fascinated" and "moved" by the book. He wrote this in the book group, but he also told me when I met him at Niffenegger's reading at Waterstone's last week. A burly man who works for London Underground, he was amused by my attempts, in these round-ups, to turn him into a woman. He said his mates at work were tickled, but they were starting to read the books, too. Actually, I think soon everyone will be reading The Time Traveler's Wife. It's already sold nearly two million copies. Move over, Dan Brown.
To join the debate over each month's book, go to http://enjoyment. independent.co.uk/books
Film review Michael Glatze biopic isn't about a self-hating gay man gone straight
Arts & Ents blogs
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- 4 Video shows what happens when lava is poured onto ice
- 5 Cate Blanchett loses temper during interview: 'That's your f**king question?'
Disney's mega money-making formula: 'Human' remakes of cartoon classics are part of a lucrative, long-term creative plan
One Direction fans set up crowdfunding page to buy the band after Zayn Malik quits
Fifty Shades of Grey movie shows first sex scene 'after 40 minutes'
James May hints Top Gear days are over following Jeremy Clarkson's BBC suspension
James May hints he will not continue on Top Gear without Jeremy Clarkson
Nigel Farage brands LGBT activists 'filth' and 'scum' and accuses them of scaring away his children after they invade his local pub
Ukip supporters are 55 or older, white and socially conservative, finds British Social Attitudes Report
JK Rowling responds to fan tweeting she 'can't see' Dumbledore being gay
Russia threatens Denmark with nuclear weapons if it tries to join Nato defence shield
Jeremy Clarkson sacked live: Alan Yentob 'wouldn't rule out' ex Top Gear host's BBC return
Vote Ukip, says far-right group Britain First
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51 years since John M. Vansant Jr. was first licensed to practice law.
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- DelFly Explorer — 20 grams, 9 minutes of autonomous flight, via barometer and new stereo vision system. (via Wayne Radinsky)
- Banning Autonomous Killing Machines (Tech Republic) — While no autonomous weapons have been built yet, it's not a theoretical concern, either. Late last year, the U.S. Department of Defense (DoD) released its policy around how autonomous weapons should be used if they were to be deployed in the battlefield. The policy limits how they should operate, but definitely doesn't ban them. (via Slashdot)
- Scientific Data Lost at Alarming Rate — says scientific paper PUBLISHED BEHIND A PAYWALL.
- Security of Browser Extension Password Managers (PDF) — This research shows that the examined password managers made design decisions that greatly increase the chance of users unknowingly exposing their passwords through application-level flaws. Many of the flaws relate to the browser-integrated password managers that don't follow the same-origin policy that is crucial to browser security. In the case of password managers, this means that passwords could be filled into unintended credential forms, making password theft easier.
"science" entries
Four short links: 23 December 2013
Lightweight Flying Robot, Autonomous Weapons, Scientific Irony, and Insecurity of Password Management Extensions
Four short links: 6 December 2013
AI Book, Science Superstars, Engineering Ethics, and Crowdsourced Science
- Society of Mind — Marvin Minsky's book now Creative-Commons licensed.
- Collaboration, Stars, and the Changing Organization of Science: Evidence from Evolutionary Biology — The concentration of research output is declining at the department level but increasing at the individual level. […] We speculate that this may be due to changing patterns of collaboration, perhaps caused by the rising burden of knowledge and the falling cost of communication, both of which increase the returns to collaboration. Indeed, we report evidence that the propensity to collaborate is rising over time. (via Sciblogs)
- As Engineers, We Must Consider the Ethical Implications of our Work (The Guardian) — applies to coders and designers as well.
- Eyewire — a game to crowdsource the mapping of 3D structure of neurons.
Four short links: 4 December 2013
Zombie Drones, Algebra Through Code, Data Toolkit, and Crowdsourcing Antibiotic Discovery
- Skyjack — drone that takes over other drones. Welcome to the Malware of Things.
- Bootstrap World — a curricular module for students ages 12-16, which teaches algebraic and geometric concepts through computer programming. (via Esther Wojicki)
- Harvest — open source BSD-licensed toolkit for building web applications for integrating, discovering, and reporting data. Designed for biomedical data first. (via Mozilla Science Lab)
- Project ILIAD — crowdsourced antibiotic discovery.
Four short links: 27 November 2013
3D Fossils, Changing Drone Uses, High Scalability, and Sim Redux
- CT Scanning and 3D Printing for Paleo (Scientific American) — using CT scanners to identify bones still in rock, then using 3D printers to recreate them. (via BoingBoing)
- Growing the Use of Drones in Agriculture (Forbes) — According to Sue Rosenstock, 3D Robotics spokesperson, a third of their customers consist of hobbyists, another third of enterprise users, and a third use their drones as consumer tools. "Over time, we expect that to change as we make more enterprise-focused products, such as mapping applications," she explains. (via Chris Anderson)
- Serving 1M Load-Balanced Requests/Second (Google Cloud Platform blog) — 7m from empty project to serving 1M requests/second. I remember when 1 request/second was considered insanely busy. (via Forbes)
- Boil Up — behind the scenes for the design and coding of a real-time simulation for a museum's science exhibit. (via Courtney Johnston)
Four short links: 26 November 2013
Internet Cities, Defying Google Glass, Deep Learning Book, and Open Paleoanthropology
- The Death and Life of Great Internet Cities — "The sense that you were given some space on the Internet, and allowed to do anything you wanted to in that space, it's completely gone from these new social sites," said Scott. "Like prisoners, or livestock, or anybody locked in institution, I am sure the residents of these new places don't even notice the walls anymore."
- What You're Not Supposed To Do With Google Glass (Esquire) — Maybe I can put these interruptions to good use. I once read that in ancient Rome, when a general came home victorious, they'd throw him a triumphal parade. But there was always a slave who walked behind the general, whispering in his ear to keep him humble. "You are mortal," the slave would say. I've always wanted a modern nonslave version of this — a way to remind myself to keep perspective. And Glass seemed the first gadget that would allow me to do that. In the morning, I schedule a series of messages to e-mail myself throughout the day. "You are mortal." "You are going to die someday." "Stop being a selfish bastard and think about others." (via BoingBoing)
- Neural Networks and Deep Learning — Chapter 1 up and free, and there's an IndieGogo campaign to fund the rest.
- What We Know and Don't Know — That highly controlled approach creates the misconception that fossils come out of the ground with labels attached. Or worse, that discovery comes from cloaked geniuses instead of open discussion. We're hoping to combat these misconceptions by pursuing an open approach. This is today's evolutionary science, not the science of fifty years ago We're here sharing science. […] Science isn't the answers, science is the process. Open science in paleoanthropology.
Handling Data at a New Particle Accelerator
Unlocking Scientific Data with Python
Most people working on complex software systems have had That Moment, when you throw up your hands and say "If only we could start from scratch!" Generally, it's not possible. But every now and then, the chance comes along to build a really exciting project from the ground up.
In 2011, I had the chance to participate in just such a project: the acquisition, archiving and database systems which power a brand-new hypervelocity dust accelerator at the University of Colorado.
Four short links: 12 November 2013
Coding for Unreliability, AirBnB JS Style, Category Theory, and Text Processing
- Quantitative Reliability of Programs That Execute on Unreliable Hardware (MIT) — As MIT's press release put it: Rely simply steps through the intermediate representation, folding the probability that each instruction will yield the right answer into an estimation of the overall variability of the program's output. (via Pete Warden)
- AirBNB's Javascript Style Guide (Github) — A mostly reasonable approach to JavaScript.
- Category Theory for Scientists (MIT Courseware) — Scooby snacks for rationalists.
- Textblob — Python open source text processing library with sentiment analysis, PoS tagging, term extraction, and more.
Four short links: 18 October 2013
Publishing Bad Research, Reproducing Research, DIY Police Scanner, and Inventing the Future
- Science Not as Self-Correcting As It Thinks (Economist) — REALLY good discussion of the shortcomings in statistical practice by scientists, peer-review failures, and the complexities of experimental procedure and fuzziness of what reproducibility might actually mean.
- Reproducibility Initiative Receives Grant to Validate Landmark Cancer Studies — The key experimental findings from each cancer study will be replicated by experts from the Science Exchange network according to best practices for replication established by the Center for Open Science through the Center's Open Science Framework, and the impact of the replications will be tracked on Mendeley's research analytics platform. All of the ultimate publications and data will be freely available online, providing the first publicly available complete dataset of replicated biomedical research and representing a major advancement in the study of reproducibility of research.
- $20 SDR Police Scanner — using software-defined radio to listen to the police band.
- Reimagine the Chemistry Set — $50k prize in contest to design a "chemistry set" type kit that will engage kids as young as 8 and inspire people who are 88. We're looking for ideas that encourage kids to explore, create, build and question. We're looking for ideas that honor kids' curiosity about how things work. Backed by the Moore Foundation and Society for Science and the Public.
Four short links: 16 October 2013
New Math, Business Math, Summarising Text, Clipping Images
- Scientific Data Has Become So Complex, We Have to Invent New Math to Deal With It (Jennifer Ouellette) — Yale University mathematician Ronald Coifman says that what is really needed is the big data equivalent of a Newtonian revolution, on par with the 17th century invention of calculus, which he believes is already underway.
- Is Google Jumping the Shark? (Seth Godin) — Public companies almost inevitably seek to grow profits faster than expected, which means beyond the organic growth that comes from doing what made them great in the first place. In order to gain that profit, it's typical to hire people and reward them for measuring and increasing profits, even at the expense of what the company originally set out to do. Eloquent redux.
- textteaser — open source text summarisation algorithm.
- Clipping Magic — Instantly create masks, cutouts, and clipping paths online.


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HAVE: about 6 trades of hibiscus rosa sinesis
christine_gardenerOctober 22, 2006
I have about 6 1 cutting each trades or a 2 couple of cuttings trades. I have 2 cuttings of El Capitolio sport(peach),2 cuttings of double dark pink, 2 cuttings of yellow wing(single bloom) and 2 cuttings of a loose double white I think this one is called elephant ear. I am looking to trade for other types of hibiscus rosa sinesis that I don't have. let me know if interested.


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Falling Tree Takes Down Muni Lines, Blocks Traffic Along San Francisco Street
A tree fell on a sidewalk, taking down Muni power lines and blocking lanes of traffic on a major thoroughfare in San Francisco Sunday.
Cars Suspected Of Racing In San Jose Lose Control, Collide, Then Fatally Strike Pedestrian
The drivers of two cars that might have been racing in East San Jose have been taken into custody Monday afternoon following a fatal collision with a female pedestrian who was pinned against a tree, San Jose police said.
Palo Alto Demands Fix For Loose Glass Shards Found In Sidewalks
Officials in Palo Alto asked a contractor to repair sidewalks along a downtown street, after complaints that the polished glass in the sidewalks has become a hazard for pedestrians.
Video Shows San Francisco Restaurant Worker 'Tenderizing' Meat On Sidewalk
A viral video shot outside a San Francisco restaurant may have people thinking twice about eating out.
Commentary: Bicyclists Don't Belong On The Sidewalk
The whole "bikes on the sidewalk" issue is in the news this week because San Jose's City Council is scheduled to vote on banning sidewalk bike riding in the downtown area, thus joining San Francisco, Oakland and many other cities with similar laws.
More Than 20,000 Sign Petition To Block Proposed Sidewalk Toll On Golden Gate Bridge
The Golden Gate Bridge, Highway and Transportation District Board of Directors has been considering a fee for pedestrians and bicyclists who cross the span.
Golden Gate Bridge District Vote Keeps Sidewalk-Toll Plan For Cyclists-Pedestrians On The Table
A proposal to look into charging a toll for pedestrians and bicyclists to use the sidewalks on the Golden Gate Bridge will move forward after the bridge district board took a Friday vote.
Pedestrian-Cyclist Toll Coming To The Golden Gate Bridge? District Facing $33 Million Deficit
The Golden Gate Bridge District is revisiting a proposal to charge a sidewalk toll for people who walk or bike across the iconic span.
Rainbow Honor Walk Unveiled In San Francisco's Castro District
A Rainbow Honor Walk was unveiled in the Castro District in San Francisco Tuesday.
San Francisco Pedestrians Could Be Fined For Violating Crosswalk Countdown Rules
While San Francisco cracks down on dangerous drivers in an attempt to increase pedestrian safety, it may come as a surprise to some that the last minute dash some pedestrians make to cross a street can them some hefty fines as well.


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Holiday Inn Sanibel Island, Sanibel
On the beach in Sanibel (Sanibel Captiva Island), Holiday Inn Sanibel Island is close to Sanibel and Captiva Island Visitor's Center, Dunes Golf and Tennis Club, and Gulfside City Park. Also nearby are Herb Strauss Schoolhouse Theater and Sanibel Public Library.
Hotel Features.
This beach hotel offers a restaurant and a poolside bar. Wireless Internet access is complimentary in public areas. Additional amenities include an outdoor pool, multilingual staff, and gift shops/newsstands. Complimentary self parking is available onsite for guests.
The 98 guestrooms at Holiday Inn Sanibel Island include safes and complimentary newspapers. Guests can use the in-room complimentary wireless and wired high-speed Internet access. Televisions are equipped with premium satellite channels. All accommodations provide desks along with free local calls (restrictions may apply). All units feature microwaves, refrigerators, and coffee/tea makers. Additional amenities include hair dryers and irons/ironing boards.
Way overpriced for what it was. Disappointed will not go to this location again. Last…
Terrific location next to beach but far enough from busy Periwinkle Way A true delight
Enter dates to check prices
Hotel Info: 866-539-8117from $325
- Traditional Two Double Beds Smoking
- Traditional One Double Bed Smoking
- Room, 1 King Bed, Accessible, Non Smoking
- Traditional Room, 2 Double Beds, Non Smoking
- Traditional Room, 2 Queen Beds, Non Smoking
- Traditional Room, 1 King Bed, Non Smoking
- Standard Room
Recommended hotels
At a glance
Key facts
Hotel size
- This hotel has 98 rooms
- This hotel is arranged over 2 floors
- Check-in time starts at 3 PM
- Check-out time is 11 AM
Required at check in
- Credit card or cash deposit required
- Government-issued photo ID required
Travelling with others
- Pets not allowed
- Free WiFi in public areas
- Free WiFi and wired Internet access in rooms
- Free self parking
- Accessible parking
Nearby Three Star Sanibel hotels
In the hotel
- Breakfast daily (surcharge)
- Restaurant
- Poolside bar
- Room service (during limited hours)
- Coffee/tea in the lobby
- Outdoor pool
- 24-hour front desk
- Free newspapers in lobby
- ATM/banking
- Safe-deposit box at front desk
- Disabled parking
- Accessible path of travel
- Braille or raised signage
- Accessibility equipment for the deaf
- Accessible bathroom
- In-room accessibility
- Roll-in shower
In the room
- Climate control
- Coffee/tea maker
- Iron/ironing board
- Hair dryer
- Premium TV channels
- Desk
- Free newspaper
- Free WiFi
- Free local calls
- Refrigerator
- Microwave
- In-room safe
Top Sanibel hotels
Recently reviewed hotels in Sanibel
- Fairways Inn of NaplesFrom
"Excellent value. Great location."Mar 8, 2015
- Trianon Bonita BayFrom
"Very nice. The only thing I would suggest is to have the continental breakfast included in the price as most other hotels do. It should be a courtesy."Mar 8, 2015
- Gulfview Manor ResortFrom
"Absolutely beautiful oceanfront, very clean nice finishes. Office staff needs to be more welcoming. Just a little rude."Mar 8, 2015
- La Quinta Inn Fort Myers CentralFrom
Nearby hotels
Special features
DiningStarfish Grille - This restaurant serves breakfast, lunch, and dinner. Guests can enjoy drinks at the bar.
The Star Bar - This bar serves lunch and light fare.
Holiday Inn Sanibel Island, Sanibel's small print
Also known as
- Sanibel Island Lodge
- Hotel Rooms in Sanibel Island
- Hotel Sanibel Island Discounts
- Sanibel Island Room Rates
- Holiday Inn Sanibel Island
- Sanibel Island Rooms
- Holiday Inn Sanibel Island Fort Myers
- Sanibel Island Hotel Rooms
- Holiday Inn Sanibel
- Sanibel Island Florida
Optional extras
Rollaway beds are available for USD 15. per night
We have included all charges provided to us by this hotel. However, charges can vary, for example, based on length of stay or the room you book.