text: From Wikipedia, the free encyclopedia Food and Drug Administration (United States) Food and Drug Administration (United States) Food and Drug Administration travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques. Organization FDA Logo Agency overview Formed Preceding agencies 1906[1] Food, Drug, and Insecticide Administration (July 1927 to July 1930) Bureau of Chemistry, USDA (July 1901 through July 1927) Division of Chemistry, USDA (Established 1862) Jurisdiction Headquarters Employees Annual budget Agency executive Parent agency Website www.fda.gov Federal government of the United States 10903 New Hampshire Ave, Silver Spring, MD 20993 9,300 (2008) $2.3 billion (2008) Margaret Hamburg, Commissioner-designate Department of Health and Human Services The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate The FDA is an agency within the United States Department of Health and Human Services responsible for protecting and promoting the nation's public health. The FDA is headquartered in Rockville, MD with 223 field offices[2] supported by 13 laboratories located throughout the United States, the U.S. Virgin Islands, and Puerto Rico. In recent years the agency began undertaking a large-scale effort to consolidate its DC-metro area operations from its main headquarters in Rockville and several fragmented office buildings in the vicinity to the former site of the Naval Ordnance Laboratory in the White Oak area of Silver Spring, MD. When FDA arrived, the site was renamed from the White Oak Naval Surface Warfare Center to the White Oak Federal Research Center. The first building, a Life Sciences Laboratory, was dedicated and opened with 104 employees on the campus in December 2003. The project is slated to be completed by 2013. The agency is organized into the following major subdivisions, each focused on a major area of regulatory responsibility: • The Office of the Commissioner (OC) • The Center for Drug Evaluation and Research (CDER) • The Center for Biologics Evaluation and Research (CBER) • The Center for Food Safety and Applied Nutrition (CFSAN) • The Center for Devices and Radiological Health (CDRH) • The Center for Veterinary Medicine (CVM) • The National Center for Toxicological Research (NCTR) • The Office of Regulatory Affairs (ORA) • The Office of Criminal Investigations (OCI) While most of the Centers are located around the Washington, D.C., area as part of the 1 From Wikipedia, the free encyclopedia Food and Drug Administration (United States) Headquarters divisions, ORA and OCI are primarily field offices, with their workforce spread across the country. ORA is considered the "eyes and ears" of the agency, conducting the vast majority of the field work the Agency. Consumer Safety Officers, more commonly called Investigators, are the individuals who inspect production and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 13 districts. Districts are based roughly on the geographic divisions of the Judicial System. Each district comprises a main district office, and a number of Resident Posts, which are FDA offices located away from the district office to serve a particular geographic area. ORA also includes the Agency's network of laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices. OCI was established in 2002 to help relieve ORA of the burden of pursuing and proving criminal cases. Unlike ORA Investigators, OCI Special Agents are armed, and are not focused on the technical aspects of whether a regulated product meets the standards under the law. Rather, OCI agents pursue and develop cases where criminal actions have occurred, such as fraudulent claims, or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI will pursue cases where Title 18 (18 USC XXXX) violations have occurred (e.g. conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of the FD&C Act (21 USC XXX). OCI Special Agents often come from other criminal investigations backgrounds, and work closely with the FBI, US Assistant Attorney Generals, and even Interpol. OCI will receive cases from a variety of sources, including ORA, local agencies, and the FBI, and will work with ORA investigators to help develop the technical and science-based aspects of a case. OCI is a much smaller branch, comprising of about 200 agents nationwide. The FDA frequently works in conjunction with other Federal agencies including the Department of Agriculture, Drug Enforcement Administration, Customs and Border Protection, and Consumer Product Safety Commission. Often local and state government agencies also work in cooperation with the FDA to provide regulatory inspections and enforcement action. Scope and funding The FDA regulates more than $1 trillion worth of consumer goods, about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. Much of the expenditures is for goods imported into the United States; the FDA is responsible for monitoring a third of all imports.[3] The FDA's federal budget request for fiscal year (FY) 2008 (October 2007 through September 2008) totaled $2.1 billion, a $105.8 million increase from what it received for fiscal year 2007.[4] In February 2008, the FDA announced that the Bush Administration's FY 2009 budget request for the agency was just under $2.4 billion: $1.77 billion in budget authority (federal funding) and $628 million in user fees. The requested budget authority was an increase of $50.7 million more than the FY 2008 funding - about a three percent increase. In June 2008, Congress gave the agency an emergency appropriation of $150 million for FY 2008 and another $150 million for FY 2009.[3] Legal authority Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act,[5] (first passed in 1938 and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act, parts of the Controlled Substances Act, the Federal AntiTampering Act, as well as many others. in many cases these responsibilities are shared with other federal agencies. Important enabling legislation for the FDA includes: • 1902 – Biologics Control Act • 1906 – Pure Food and Drug Act 2 From Wikipedia, the free encyclopedia Food and Drug Administration (United States) • 1938 – Federal Food, Drug, and Cosmetic Act • 1944 – Public Health Service Act • 1951 – Food, Drug, and Cosmetics Act Amendments PL 82–215 • 1962 – Food, Drug, and Cosmetics Act Amendments PL 87–781 • 1966 – Fair Packaging and Labeling Act PL 89–755 • 1976 – Medical Device Regulation Act PL 94–295 • 1987 – Prescription Drug Marketing Act • 1988 – Anti–drug Abuse Act PL 100–690 • 1990 – Nutrition Labeling and Education Act PL 101–535 • 1992 – Prescription Drug User Fee Act PL 102–571 • 1994 – Dietary Supplement Health and Education Act • 1997 – Food and Drug Modernization Act 105-115 • 2002 – Bioterrorism Act 107-188 • 2002 – Medical Device User Fee and Modernization Act (MDUFMA) PL 107-250 • 2003 – Animal Drug User Fee Act PL 108-130 • 2007 – Food and Drug Administration Amendments Act of 2007 which contain minimal amounts of meat are regulated by FDA, and the exact boundaries are listed in a memorandum of understanding between the two agencies. However, medicines and other products given to all domesticated animals are regulated by the FDA through a different branch, the Center for Veterinary Medicine. Other consumables which are not regulated by the FDA include beverages containing more than 7% alcohol (regulated by the Bureau of Alcohol, Tobacco, Firearms and Explosives in the Department of Justice), and non-bottled drinking water (regulated by the United States Environmental Protection Agency (EPA)). CFSAN's activities include establishing and maintaining food standards, such as standards of identity (for example, what the requirements are for a product to be labeled, "yogurt") and standards of maximum acceptable contamination. CFSAN also sets the requirements for nutrition labeling of most foods. Both food standards and nutrition labeling requirements are part of the Code of Federal Regulations. The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplements as foods, rather than as drugs. Therefore, dietary supplements are not subject to safety and efficacy testing and there are no approval requirements. The FDA can take action against dietary supplements only after they are proven to be unsafe. Manufacturers of dietary supplements are permitted to make specific claims of health benefits, referred to as "structure or function claims" on the labels of these products. They may not claim to treat, diagnose, cure, or prevent disease and must include a disclaimer on the label.[7] Bottled water is regulated in America by the FDA.[8] State governments also regulate bottled water. Tap water is regulated by state and local regulations, as well as the United States EPA. FDA regulations of bottled water generally follow the guidelines established by the EPA, and new EPA rules automatically apply to bottled water if the FDA does not release an explicit new rule.[9] Water bottlers in the US are subject to inspection similar to other food firms, but quality controls for the bottled water industry are not nearly as stringent as those for municipal water supplies. Regulatory programs The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety, yet FDA regulation of cosmetics is focused primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Food and dietary supplements The Center for Food Safety and Applied Nutrition is the branch of the FDA which is responsible for ensuring the safety and accurate labeling of nearly all food products in the United States.[6] One exception is meat products derived from traditional domesticated animals, such as cattle and chickens, which fall under the jurisdiction of the United States Department of Agriculture Food Safety and Inspection Service. Products 3 From Wikipedia, the free encyclopedia Food and Drug Administration (United States) Drugs Regulation of therapeutic goods in the United States by the FDA in order to be able to add the particular application to the "uses" listed on the label. However it is entirely legal and professionally proper for physicians to prescribe the medication for any use for which there exists sufficient scientific research from any source, indicating it is or may be efficacious for that purpose. The test of propriety for offlabel uses is whether the prescription meets the "standard of practice" among physicians. Post market safety surveillance After approval of an NDA, the sponsor must review and report to the FDA every patient adverse drug experience of which it learns. Unexpected serious and fatal adverse drug events must be reported within 15 days; other events on a quarterly basis.[11] The FDA also receives directly adverse drug event reports through its MedWatch program.[12] These reports are called '"spontaneous reports" because reporting by consumers and health professionals is voluntary. While this remains the primary tool of postmarket safety surveillance, FDA requirements for postmarketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials. In some cases the FDA requires risk management plans for some drugs that may provide for other kinds of studies, restrictions, or safety surveillance activities. Prescription drugs Over-the-counter drugs The Center for Drug Evaluation and Research has different requirements for the three main types of drug products: new drugs, generic drugs and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to "new molecular entities": drugs which are not based on existing medications. New drugs New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA. New drugs are available only by prescription by default. A change to Over the Counter (OTC) status is a separate process and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed." Advertising and promotion The FDA reviews and regulates prescription drug advertising and promotion. (Other kinds of advertising, including for over-the- counter drugs, are regulated by the Federal Trade Commission). The drug advertising regulation[10] contains two key requirements. Under most circumstances, a company may only advertise a drug for the specific indication or medical use for which it was approved. "Off-label use", using a drug for other than its approved purpose, is common in medical practice. Also, an advertisement must contain "fair balance" between the benefits and risks of a drug. The term "off-label", often now used with a vaguely pejorative connotation, actually may mean only that the pharmaceutical company did not choose to invest in the lengthy and costly regimen of clinical trials required Generic drugs Generic drugs are chemical equivalents of name-brand drugs whose patents have expired.[13] Generally they are less expensive then their name brand counterparts, are manufactured and marketed by other companies and, in the 1990s, accounted for about a third of all prescriptions written in the United States.[13] For approval of a generic drug, the U.S. Food and Drug Administration (FDA) requires scientific evidence that the generic drug is interchangeable or therapeutically equivalent with the originally approved drug.[14] This is called an "ANDA" (Abbreviated New Drug Application). Generic drug scandal In 1989 a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public.[13] Charges of corruption in generic drug approval first emerged in 1988, in the course of 4 From Wikipedia, the free encyclopedia Food and Drug Administration (United States) an extensive congressional investigation into the FDA. The oversight subcommitee of the United States House Energy and Commerce Committee resulted from a complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh. When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, began its own private investigation of the agency in 1987. Mylan eventually filled suit against two former FDA employees and for drug-manufacturing companies, charging that corruption within the federal agency resulted in racketeering and in violations of antitrust law. "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and according to Mylan this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989 three FDA officials pleaded guilty to criminal charges of accepting bribes from generic drugs makers and two companies pleaded guilty to giving bribes. Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide, a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989 the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were enventually suspended or recalled by manufacturers. In the early 1990s the U.S. Securities and Exchange Commission filed "securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York.[13] Vaccines, blood and tissue products, and biotechnology The Center for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents.[16] These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a pre-market approval process similar to that for drugs. The original authority for government regulation of biological products was established by the 1902 Biologics Control Act, with additional authority established by the 1944 Public Health Service Act. Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health; this authority was transferred to the FDA in 1972. Medical and radiation-emitting devices The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices.[17] The definition of a medical device is given in the FD&C Act, and it includes products from the simple toothbrush to complex devices such as implantable brain pacemakers. CDRH also oversees the safety performance of non-medical devices which emit certain types of electromagnetic radiation. Examples of CDRH-regulated devices include cellular phones, airport baggage screening equipment, television receivers, microwave ovens, tanning booths, and laser products. CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing. Over-the-counter drugs Over-the-counter (OTC) drugs are drugs and combinations that do not require a doctor's prescription. The FDA has a list of approximately 800 approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without a medical practitioner's supervision. [15] 5 From Wikipedia, the free encyclopedia Food and Drug Administration (United States) Cosmetics Cosmetics are regulated by the Center for Food Safety and Applied Nutrition, the same branch of the FDA that regulates food. Cosmetic products are not generally subject to pre-market approval by the FDA unless they make "structure or function claims" which make them into drugs (see Cosmeceutical). However, all color additives must be specifically approved by the FDA before they can be included in cosmetic products sold in the U.S. The labeling of cosmetics is regulated by the FDA, and cosmetics which have not been subjected to thorough safety testing must bear a warning to that effect. Early history Origins of federal food and drug regulation Up until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals, with one exception being the shortlived Vaccine Act of 1813. A patchwork of state laws provided varying degrees of protection against unethical sales practices, such as misrepresenting the ingredients of food products or therapeutic substances. The history of the FDA can be traced to the latter part of the 19th century and the U.S. Department of Agriculture's Division of Chemistry (later Bureau of Chemistry). Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market. Although they had no regulatory powers, the Division published its findings from 1887 to 1902 in a ten-part series entitled Foods and Food Adulterants. Wiley used these findings, and alliances with diverse organizations such as state regulators, the General Federation of Women's Clubs, and national associations of physicians and pharmacists, to lobby for a new federal law to set uniform standards for food and drugs to enter into interstate commerce. Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by muckraking journalists like Upton Sinclair, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the Progressive Era.[19] The 1902 Biologics Control Act was put in place after diphtheria antitoxin was collected from a horse named Jim who also had tetanus , resulting in several deaths. Cosmetic products Though the cosmetic industry is predominantly responsible in ensuring the safety of its products, the FDA also has the power to intervene when necessary to protect the public but does not generally require pre-market approval or testing. Companies are required to place a warning note on their products if they have not been tested. Experts in cosmetic ingredient reviews also play a role in monitoring safety through influence on the use of ingredients, but also lack legal authority. Overall the organization has reviewed about 1,200 ingredients and has suggested that several hundred be restricted, but there is no standard or systemic method for reviewing chemicals for safety and a clear definition of what is meant by 'safety' so that all chemicals are tested on the same basis.[18] Veterinary products The Center for Veterinary Medicine (CVM) is the branch of the FDA which regulates food, food additives, and drugs that are given to animals, including food animals and pets. CVM does not regulate vaccines for animals; these are handled by the United States Department of Agriculture. CVM's primary focus is on medications that are used in food animals and ensuring that they do not affect the human food supply. The FDA's requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers. The 1906 Food and Drugs Act and creation of the FDA In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the "Wiley Act" after its chief advocate.[19] The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated", with that term referring to the addition of fillers of reduced "quality or strength", coloring to conceal "damage or inferiority," formulation with additives "injurious to health," or the History 6 From Wikipedia, the free encyclopedia Food and Drug Administration (United States) use of "filthy, decomposed, or putrid" substances. The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the United States Pharmacopoeia or the National Formulary. The act also banned "misbranding" of food and drugs.[20] The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.[19] Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, as well as by the creation of the Board of Food and Drug Inspection and the Referee Board of Consulting Scientific Experts as separate organizations within the USDA in 1907 and 1908 respectively. A 1911 Supreme Court decision ruled that the 1906 act did not apply to false claims of therapeutic efficacy,[21] in response to which a 1912 amendment added "false and fraudulent" claims of "curative or therapeutic effect" to the Act's definition of "misbranded." However, these powers continued to be narrowly defined by the courts, which set high standards for proof of fraudulent intent.[19] In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later.[22] that the FDA could even seize the product was due to a misbranding problem: an "Elixir" was defined as a medication dissolved in ethanol, not the diethylene glycol used in the Elixir Sulfanilamide. President Franklin Delano Roosevelt signed the new Food, Drug, and Cosmetic Act (FD&C Act) into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent. The law also authorized factory inspections and expanded enforcement powers, set new regulatory standards for foods, and brought cosmetics and therapeutic devices under federal regulatory authority. This law, though extensively amended in subsequent years, remains the central foundation of FDA regulatory authority to the present day.[19] Regulation of human drugs and medical devices after 1938 Early FD&C Act amendments: 1938-1958 Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of 'prescription-only' drugs was securely codified into law by the 1951 Durham-Humphrey Amendment.[19] While pre-market testing of drug efficacy was not authorized under the 1938 FD&C Act, subsequent amendments such as the Insulin Amendment and Penicillin Amendment did mandate potency testing for formulations of specific lifesaving pharmaceuticals.[22] The FDA began enforcing its new powers against drug manufacturers who could not substantiate the efficacy claims made for their drugs, and the 1950 Court of Appeals ruling in Alberty Food Products Co. v. U.S. found that drug manufacturers could not evade the "false therapeutic claims" provision of the 1938 act by simply omitting the intended use of a drug from the drug's label. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs.[19] Much of the FDA's regulatory attentions in this era were directed towards abuse of amphetamines and barbiturates, but the agency also The 1938 Food, Drug, and Cosmetic Act By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products which had been ruled permissible under the 1906 law, including radioactive beverages, cosmetics which caused blindness, and worthless "cures" for diabetes and tuberculosis. The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent. The only way 7 From Wikipedia, the free encyclopedia Food and Drug Administration (United States) reviewed some 13,000 new drug applications between 1938 and 1962. While the science of toxicology was in its infancy at the start of this era, rapid advances in experimental assays for food additive and drug safety testing were made during this period by FDA regulators and others.[19] These reforms had the effect of delaying the time it took a drug to come to market.[25] In the mid-1970s, 13 of the 14 drugs the FDA saw as most important to approve were on the market in other countries before the United States.[25] One of the most important statutes in establishing the modern American pharmaceutical market was the 1984 Drug Price Competition and Patent Term Restoration Act, more commonly known as the "Hatch-Waxman Act" after its chief sponsors. This act was intended to correct two unfortunate interactions between the new regulations mandated by the 1962 amendments, and existing patent law (which is not regulated or enforced by the FDA, but rather by the United States Patent and Trademark Office). Because the additional clinical trials mandated by the 1962 amendments significantly delayed the marketing of new drugs, without extending the duration of the manufacturer's patent, "pioneer" drug manufacturers experienced a decreased period of lucrative market exclusivity. On the other hand, the new regulations could be interpreted to require complete safety and efficacy testing for generic copies of approved drugs, and "pioneer" manufacturers obtained court decisions which prevented generic manufacturers from even beginning the clinical trial process while a drug was still under patent. The Hatch-Waxman Act was intended as a compromise between the "pioneer" and generic drug manufacturers which would reduce the overall cost of bringing generics to market and thus, it was hoped, reduce the long-term price of the drug, while preserving the overall profitability of developing new drugs. The act extended the patent exclusivity terms of new drugs, and importantly tied those extensions, in part, to the length of the FDA approval process for each individual drug. For generic manufacturers, the Act created a new approval mechanism, the Abbreviated New Drug Application (ANDA), in which the generic drug manufacturer need only demonstrate that their generic formulation has the same active ingredient, route of administration, dosage form, strength, and pharmacokinetic properties ("bioequivalence") as the corresponding brand-name drug. This act has been credited with essentially creating the modern generic drug industry.[26] Expansion of premarket approval process: 1959-1985 In 1959, Senator Estes Kefauver began holding congressional hearings into concerns about pharmaceutical industry practices, such as the perceived high cost and uncertain efficacy of many drugs promoted by manufacturers. There was significant opposition, however, to calls for a new law expanding the FDA's authority. This climate was rapidly changed by the thalidomide tragedy, in which thousands of European babies were born deformed after their mothers took that drug - marketed for treatment of nausea during their pregnancies. Thalidomide had not been approved for use in the U.S. due to the concerns of an FDA reviewer, Frances Oldham Kelsey. However, thousands of "trial samples" had been sent to American doctors during the "clinical investigation" phase of the drug's development, which at the time was entirely unregulated by the FDA. Individual members of Congress cited the thalidomide incident in lending their support to expansion of FDA authority.[23] The 1962 Kefauver-Harris Amendment to the FD&C act represented a "revolution" in FDA regulatory authority.[24] The most important change was the requirement that all new drug applications demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety. This marked the start of the FDA approval process in its modern form. Drugs approved between 1938 and 1962 were also subject to FDA review of their efficacy, and to potential withdrawal from the market. Other important provisions of the 1962 amendments included the requirement that drug companies use the "established" or "generic" name of a drug along with the trade name, the restriction of drug advertising to FDA-approved indications, and expansion of FDA powers to inspect drug manufacturing facilities. 8 From Wikipedia, the free encyclopedia Food and Drug Administration (United States) FDA reforms in the AIDS era Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the mid- and late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections, and staged large protests, such as a confrontational October 11, 1988 action at the FDA campus which resulted in nearly 180 arrests.[27] In August 1990, Dr. Louis Lasagna, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer and AIDS.[28] Partly in response to these criticisms, the FDA issued new rules to expedite approval of drugs for life threatening diseases, and expanded pre-approval access to drugs for patients with limited treatment options.[29] The first of these new rules was the "IND exemption" or "treatment IND" rule, which allowed expanded access to a drug undergoing phase II or III trials (or in extraordinary cases even earlier) if it potentially represented a safer or better alternative to treatments currently available for terminal or serious illness. A second new rule, the "parallel track policy", allowed a drug company to set up a mechanism for access to a new potentially lifesaving drug by patients who for various reasons would be unable to participate in ongoing clinical trials. The "parallel track" designation could be made at the time of IND submission. The accelerated approval rules were further expanded and codified in 1992.[30] All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated approval mechanisms. For example, a "treatment IND" was issued for the first HIV drug, AZT, in 1985, and approval was granted just two years later in 1987.[31] Three of the first five drugs targeting HIV were approved in the United States before they were approved in any other country.[32] Critical Path Initiative The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDAregulated products are developed, evaluated, and manufactured. The Initiative was launched in March 2004, with the release of a report entitled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products [21]. Patients' rights to access unapproved drugs A 2006 court case, Abigail Alliance v. von Eschenbach, would have forced radical changes in FDA regulation of unapproved drugs. The Abigail Alliance argued that the FDA must license drugs for use by terminally ill patients with "desperate diagnoses," after they have completed Phase I testing.[33] The case won an initial appeal in May 2006, but that decision was reversed by a March 2007 rehearing. The US Supreme Court declined to hear the case, and the final decision denied the existence of a right to unapproved medications. Post-marketing drug safety monitoring The widely publicized recall of Vioxx, a nonsteroidal anti-inflammatory drug now estimated to have contributed to fatal heart attacks in thousands of Americans, played a strong role in driving a new wave of safety reforms at both the FDA rulemaking and statutory levels. Vioxx was approved by the FDA in 1999, and was initially hoped to be safer than previous NSAIDs, due to its reduced risk of intestinal tract bleeding. However, a number of pre- and post-marketing studies suggested that Vioxx might increase the risk of myocardial infarction, and this was conclusively demonstrated by results from the APPROVe trial in 2004.[34] Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the market. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition. In the wake of the Vioxx recall, there were widespread calls by major newspapers, medical journals, consumer advocacy organizations, Recent and ongoing reforms 9 From Wikipedia, the free encyclopedia Food and Drug Administration (United States) lawmakers, and FDA officials[35] for reforms in the FDA's procedures for pre- and postmarket drug safety regulation. In 2006, a congressionally requested committee was appointed by the Institute of Medicine to review pharmaceutical safety regulation in the U.S. and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicinemedical research, economics, biostatistics, law, public policy, public health, and the allied health professions, as well as current and former executives from the pharmaceutical, hospital, and health insurance industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.[36][37] Some of the committee's recommendations have been incorporated into drafts of the PDUFA IV bill which was signed into law in 2007.[38] had not been tested for pediatric safety and efficacy to bear a disclaimer to that effect. However, this rule failed to motivate many drug companies to conduct additional pediatric drug trials. In 1997, the FDA proposed a rule to require pediatric drug trials from the sponsors of New Drug Applications. However, this new rule was successfully preempted in Federal court as exceeding the FDA's statutory authority. While this debate was unfolding, Congress used the 1997 Food and Drug Administration Modernization Act to pass incentives which gave pharmaceutical manufacturers a six-month patent term extension on new drugs submitted with pediatric trial data. The act reauthorizing these provisions, the 2002 Best Pharmaceuticals for Children Act, allowed the FDA to request NIH-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints. Most recently, in the Pediatric Research Equity Act of 2003, Congress codified the FDA's authority to mandate manufacturer-sponsored pediatric drug trials for certain drugs as a "last resort" if incentives and publicly funded mechanisms proved inadequate.[39] Pediatric drug testing Prior to the 1990s, only 20% of all drugs prescribed for children in the United States were tested for safety or efficacy in a pediatric population. This became a major concern of pediatricians as evidence accumulated that the physiological response of children to many drugs differed significantly from those drugs' effects on adults. The reasons for the death of clinical drug testing in children were multifactorial. For many drugs, children represented such a small proportion of the potential market, that drug manufacturers did not see such testing as cost-effective. Also, because children were thought to be ethically restricted in their ability to give informed consent, there were increased governmental and institutional hurdles to approval of these clinical trials, as well as greater concerns about legal liability. Thus, for decades, most medicines prescribed to children in the U.S. were done so in a non-FDA-approved, "off-label" manner, with dosages "extrapolated" from adult data through body weight and body-surface-area calculations.[39] An initial attempt by the FDA to address this issue was the 1994 FDA Final Rule on Pediatric Labeling and Extrapolation, which allowed manufacturers to add pediatric labeling information, but required drugs which Rules for generic biologics Since the 1990s, many successful new drugs for the treatment of cancer, autoimmune diseases, and other conditions have been protein-based biotechnology drugs, regulated by the Center for Biologics Evaluation and Research. Many of these drugs are extremely expensive; for example, the anti-cancer drug Avastin costs $55,000 for a year of treatment, while the enzyme replacement therapy drug Cerezyme costs $200,000 per year, and must be taken by Gaucher's Disease patients for life. Biotechnology drugs do not have the simple, readily verifiable chemical structures of conventional drugs, and are produced through complex, often proprietary techniques, such as transgenic mammalian cell cultures. Because of these complexities, the 1984 Hatch-Waxman Act did not include biologics in the Abbreviated New Drug Application (ANDA) process, essentially precluding the possibility of generic drug competition for biotechnology drugs. In February 2007, identical bills were introduced into the House to create an ANDA process for the approval of generic biologics, but were not passed.[40] 10 From Wikipedia, the free encyclopedia Food and Drug Administration (United States) Criticism The FDA currently has regulatory oversight over a large array of products that affect the health and life of American citizens.[19] As a result, the FDA's powers and decisions are carefully monitored by several governmental and non-governmental organizations. There are many criticisms and complaints lodged against the FDA from patients, economists, regulatory bodies, and the pharmaceutical industry. A $1.8 million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.[41][42] Nine FDA scientists appealed to then president-elect George W. Bush over pressure from management to manipulate data, mainly in relation to the review process for medical devices. These concerns were highlighted in the 2006 report[41] on the agency as well.[43] veins in such cases often are too damaged or too small to reconnect. In these cases, pooled blood around a wound can threaten tissue survival. The primary function of leeches is to drain the pooled blood and increase the chances of survival of the tissue in reattached appendages. See also • Criticism of the Food and Drug Administration • Drug Efficacy Study Implementation • European Medicines Agency • Food Administration • Food and Drug Administration Amendments Act of 2007 • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) • Investigational Device Exemption • Kefauver Harris Amendment • Medicines and Healthcare products Regulatory Agency (UK) • Pharmaceutical company • The Food Defect Action Levels, an FDA publication Regulation of living organisms With acceptance of premarket notification 510(k) 033391 in January 2004, the FDA granted Dr. Ronald Sherman permission to produce and market Medical maggots for use in humans or other animals as a prescription medical device in a medical procedure known as maggot therapy The specific indications the FDA has allowed Medical maggots to be employed in are as follows: "For debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds." Medical maggots represent the first living organism ever allowed by the Food and Drug Administration for production and marketing as a prescription medical device. In June 2004, the FDA cleared leeches (Hirudo medicinalis) as the second living organism to be used in modern medicine as medical devices. Surgeons who do plastic and reconstructive surgery find leeches especially valuable when regrafting amputated appendages, such as fingers or toes. Severed References [1] "FDA Centennial 1906-2006", US FDA, http://www.fda.gov/centennial/, retrieved on 2008-09-13. [2] "FDA 2008 ORA Field Activities" (PDF), US FDA, http://www.fda.gov/oc/oms/ofm/ budget/2009/Narratives/8_ORA.pdf, retrieved on 2008-09-13. [3] ^ Gardiner Harris (November 2, 2008), "The Safety Gap", New York Times Magazine, http://www.nytimes.com/ 2008/11/02/magazine/02fda-t.html. [4] Summary of FDA's FY 2008 Budget [5] Food, Drug and Cosmetic Act Web Version [1] [6] http://www.cfsan.fda.gov/~lrd/ cfsan4.html Overview of the Center for Food Safety and Applied Nutrition [7] Text of the Dietary Supplement Health and Education Act of 1994. Accessed 5 Feb 2007. [8] [2]PDF (106 KB) Title 21 of the Code of Federal regulations [9] http://www.dwrf.info/documents/ recent_dev_bw_quality.pdfPDF (217 KB) 11 From Wikipedia, the free encyclopedia Food and Drug Administration (United States) [10] 21 CFR 202: Prescription Drug Advertising. [11] 21 CFR 314.80: Postmarketing Reporting of Adverse Drug Experiences [12] MedWatch: The FDA Safety Information and Adverse Event Reporting Program[3]. Accessed October 9, 2007 [13] ^ Cohen, Lynne. "Government Policies and Programs - United States - Generic Drug Scandal." The New Book of Knowledge - Medicine And Health. 1990. 276-81. ISBN 0-7172-8244-9. [14] "Therapeutic Equivalence of Generic Drugs", U.S. Food and Drug Administration, 1998, http://www.fda.gov/cder/news/ nightgenlett.htm, retrieved on 2007-1010. [15] FDA CDER Handbook: Over-the- Counter Drug Products [4] Accessed October 9, 2007 [16] FDA/CBER - About CBER [17] 2005 report of the CDRH Radiological Health Program Core GroupPDF (90.3 KB) [18] Ross G (2006), "A perspective on the safety of cosmetic products: a position paper of the American Council on Science and Health", Int. J. Toxicol. 25 (4): 269–77, doi:10.1080/ 10915810600746049, PMID 16815815. [19] ^ [5] A History of the FDA at FDA.gov [20] [6] Original Text of the 1906 Food and Drugs Act and Amendments [21] United States v. Johnson, 6df1b297de555a5c 221 U.S. 488 (31 S. Ct. 627 May 29, 1911, decided). [22] ^ [7] Milestones in U.S. Food and Drug Law History at FDA.gov [23] [8] Report of Congressman Morris Udall on thalidomide and the Kefauver hearings. [24] Temple R (2002), "Policy developments in regulatory approval", Statistics in Medicine 21: 2939–2948, doi:10.1002/ sim.1298. [25] ^ Frum, David (2000). How We Got Here: The '70s. New York, New York: Basic Books. p. 180. ISBN 0465041957. [26] Karki L (2005), "Review of FDA Law Related to Pharmaceuticals: The HatchWaxman Act, Regulatory Amendments and Implications for Drug Patent Enforcement", Journal of the Patent & Trademark Office Society 87: 602–620. [27] [9] ACT-UP NY timeline [28] Faster Approval of AIDS Drugs Is Urged, The New York Times, August 16, 1990, Thursday, Late Edition - Final, Section B; Page 12, Column 4; National Desk, 830 words, By ROBERT PEAR, Special to The New York Times, Washington, Aug. 15 [29] [10] FDA Website: Expanded Access and Expedited Approval of New Therapies Related to HIV/AIDS [30] Orlando V (1999), "The FDA's Accelerated Approval Process: Does the Pharmaceutical Industry Have Adequate Incentives for Self-Regulation?", American Journal of Law and Medicine 25: 543–68. [31] [11] FDA report on accelerated approval process [32] [12] FDA press release on 3TC approval [33] [13]PDF (119 KB) Abigail Alliance Citizen Petition to FDA [34] [14] The APPROVe study (Pubmed) [35] [15]PDF (28.3 KB) David Graham's 2004 testimony to Congress [36] Henderson, Diedtra (2006-09-23), "Panel: FDA needs more power, funds", Boston Globe. [16] [37] [17]PDF (279 KB) Executive Summary of the 2006 IOM Report The Future of Drug Safety: Promoting and Protecting the Health of the Public [38] [18] The PDUFA IV Act [39] ^ Politis P (2005), "Transition From the Carrot to the Stick: The Evolution of Pharmaceutical Regulations Concerning Pediatric Drug Testing", Widener Law Review 12: 271. [40] [19] H.R. 1038 Access to Life-Saving Medicine Act [41] ^ Henderson, Diedtra (September 23, 2006). Panel: FDA needs more power, funds. [20] [42] Committee on the Assessment of the US Drug Safety System. (2006). The Future of Drug Safety: Promoting and Protecting the Health of the Public. Institute of Medicine. Free full-text. [43] Mundy A, Favole JA. (2009). FDA Scientists Ask Obama to Restructure Drug Agency. WSJ. Further reading • Michael Givel (December 2005) Philip Morris' FDA Gambit: Good for Public Health? Journal of Public Health Policy (26): pp. 450–468. 12 From Wikipedia, the free encyclopedia Food and Drug Administration (United States) • Philip J. Hilts. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation. New York: Alfred E. Knopf, 2003. ISBN 0-375-40466-X • Thomas J. Moore. Prescription for Disaster: The Hidden Dangers in Your Medicine Cabinet. New York: Simon & Schuster, 1998. ISBN 0-684-82998-3. • FDA: A History, a comprehensive history of the FDA • Strategic Plan (in XML) - from StratML • Biologics Centennial: 100 Years of Biologics Regulation – from the Food and Drug Administration Home Page • U.S. FDA CDER Home Page – the Center for Drug Evaluation and Research • CBER – Center for Biologics Evaluation and Research, FDA • Past FDA Commissioners • Communication of FDA Advice on Consumption of Fish Like Tuna and Swordfish External links • Food and Drug Administration Home Page • FDA Recalls Finder Retrieved from "http://en.wikipedia.org/wiki/Food_and_Drug_Administration_(United_States)" Categories: Food and Drug Administration, United States Department of Health and Human Services agencies, Society-related timelines, National agencies for drug regulation, Regulators of biotechnology products, Food safety organizations This page was last modified on 19 May 2009, at 22:44 (UTC). All text is available under the terms of the GNU Free Documentation License. (See Copyrights for details.) Wikipedia® is a registered trademark of the Wikimedia Foundation, Inc., a U.S. registered 501(c)(3) taxdeductible nonprofit charity. Privacy policy About Wikipedia Disclaimers 13


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Los Alamos Gardeners
Los Alamos Master Gardeners' will be held at 7 p.m. Thursday at the White Rock Town Hall. Archeologists from Bandelier National Monument, Rory Gauthier and Jamie Civitello, will speak during the meeting about the Pueblo farming techniques and the historic gardeners in Frijoles Canyon.
Enjoy the ski hill until Thursday
Skiers, remember those years when there was hardly any snow? Well, this is not the case this year. As a result, the management at Pajarito Mountain ski area decided to keep the mountain open until Thursday.
Chapter BC, P.E.O. meeting
Chapter BC, P.E.O. will meet at 9:30 a.m. April 8 at the home of Joanne Baty, 530 Paul Place in White Rock. Joanne Salzman will serve as the co-hostess. The program will be the Introduction of the Yearbook by Salzman. Call Salzman aat 672-9551 with questions or regrets.
Brown Bag Performance Series
Los Alamos Arts Council's Brown Bag Performance Series presents a winds and strings performance featuring the works of Bruch and Mozart at 12:30 p.m. April 7 at Fuller Lodge.
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where are the ponies now????Submitted by Guest99 (not verified) on Thu, 03/08/2012 - 11:11am.
some facts are missing. glad to see the owner was reprimanded, however,it would be nice to know what happened to the ponies. is someone fostering them back to good health? are they going to be sold to good homes? WHAT?? »
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Ah sure whats the worst that can happen....
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posted Mar 1 2010 10:56AM
I was out last week for CRS which stands for Country Radio Seminar. It's the better part of a week, and country programmers and station personnel head to Nashville for networking, education, and familiarizing ourselves with the new best music coming our way in the next year. There are some folks that are worth checking out. Most of these folks are pretty unknown but you will most likely hear a lot more about them in the year, and years to come.
Tyler Dickerson, a new artist on Lyric Street. Only 16 years old, but the attitude and song writing ability of someone a lot older, you can listen to his stuff on
Emily West: She was recently in town for a show at Fuel and I saw her again with her entire band. She's on the verge of turning into something big, you can listen to some of her songs on her
page also. We're currently playing Blue Sky featuring Keith Urban on the Wolf.
Josh Thompson: also makes my list for possible superstars, many of you may have heard "Beer On The Table" which was his first single. I have pretty good feeling he'll be around for at while. He has a album available now and should be available at Walmart and Target. You can hear songs from it on
Last but not least, Mallary Hope She's a new artist on MCA Records. The trend has been going toward singer song writers in Nashville for the last 5 years or so. More and more labels are searching for talented singers and songwriters. Mallary fits the bill, great voice and a great song writer. Check out some of her stuff on her
There are more that I'm missing but the good news there is a lot of fresh talent out there and some great new music you'll be hearing on the Wolf soon! (WP)
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"Pilgrim Of Eternity" - is it good enough?
View Single Post
June 3 2013, 02:19 AM
Location: Outer Graceland
Re: "Pilgrim Of Eternity" - is it good enough?
I have been more or less ignorant of them, though come to think of it, I saw the shuttle-in-garage William Windom one at a small convention in Marquette, MI. And re. my earlier Sulu comment I was replying to the recommendation to watch "World Enough."
To anyone connected with these -- I understand the tacit understanding w/ CBS is "no revenue." But I think you accept donations to the production company? They are ok with that, apparently? Still just curious, and feel free not to answer if it's to your benefit not to.
My earlier expressed interest in rights comes from writing a book about a famous figure, Louis Armstrong. I had to explore the concept of publicity rights, plus I was quoting primary sources found in secondary sources, which I had always done in academic writing. But now this one was for money (supposedly)
. So I had to explore the whole gray mess that is fair use. Just read of a case involving EA and the likeness of college football players in their video games. Athletes are on one side and speech advocates on the other.
Rambling now. Time to go watch. Be well, imaginary friends.
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text:
Iraqi worshipers attend the Easter Sunday service at the Virgin Mary Chaldean Christian church (Church of Our Lady of Sacred Heart) in the Karrada district of central Baghdad on March 31, 2013. AFP PHOTO/SABAH ARAR
BAGHDAD: Iraq's Catholic Christians flocked to churches to celebrate Easter Sunday, praying, singing and rejoicing in the resurrection of Christ behind high blast walls and tight security cordons.
It was the first Easter since the election of Pope Francis in Rome, and worshipers said they hoped their new spiritual leader would help strengthen their tiny community that has shrunk under the joint pressures of militant attacks and economic hardships.
At the St. Joseph Chaldean Church in Baghdad, some 200 worshipers stood and sat during parts of the Easter mass led by Father Saad Sirop.
"We pray for love and peace to spread through the world," said worshiper Fatin Yousef, 49. Like most worshippers she arrived have dressed immaculately for mass, her hair tumbling in salon-created curls, wearing a tidy black skirt, low-heeled pumps and a striped shirt. "We hope Pope Frances will help make it better for Christians in Iraq."
There are an estimated 400,000 to 600,000 Christians in Iraq, with most belonging to ancient eastern churches. There has been no census in Iraq for 16 years, making precise figures difficult to obtain.
An estimated two-thirds of Iraq's Christians are Catholics of the Chaldean church and the smaller Assyrian Catholic church. Worshipers of both churches chant in versions of ancient Aramaic, the language that Jesus spoke, although the dialects would be mutually unintelligible.
Since the 2003 U.S.-led invasion, Iraqi Christians have suffered repeated attacks by Islamic militants. Hundreds of thousands have left the country, with church officials estimating their communities have at least halved. The worst attack was at Baghdad's soaring Our Lady of Salvation church in October 2010. It killed more than 50 worshipers and wounded scores more.
More broadly, decades of immigration have shrunken the size of Christian communities throughout the Middle East, with most leaving for better opportunities and to join families abroad.
Other Christians in the region no longer feel comfortable among majority-Muslim communities that many believe have become more outwardly pious and politically Islamist over the decades.
They included Iraqi Christian worshiper Yousef's son, who moved to live with relatives in Arizona last year. Yousef said she was arranging for her other daughter and son to immigrate.
"There's still fear here, and there's no stability in this country," she said.
Iraqi officials have made efforts to secure churches since the violence of 2010.
High blast walls topped with netting and barbed wire surrounded the St. Joseph Church in Baghdad in the middle-class district of Karradeh. Blue-khaki clad Iraqi police guarded roads surrounding the church and checked papers of passers-by as worshipers filtered inside.
Four Iraqi Christian volunteers, two men and two women, stood at the church entrance to double-check who was coming in.
White-robed church volunteers marched down the church aisle behind Father Sirop, who chanted and waved thickly-scented incense that wafted through the building. The white-painted interior was adorned with three ornate chandeliers and a series of simple paintings illustrating the life of Christ.
Worshipers stood for lengthy passages of Sirop's mass, at one point bursting into applause when he told them, "Celebrate! You are Christians!"
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text:
Pronunciation: /ˈɡrɛnədiːn/
(also the Grenadines)
Definition of Grenadine Islands in English:
A chain of small islands in the Caribbean, part of the Windward Islands. They are divided administratively between St Vincent and Grenada.
Definition of Grenadine Islands in:
- US English dictionary
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This is a MUST HAVE for my Fourth of July experience. I mean could it be anymore flashy.
All American!
Added 4 Years Ago from Urban Outfitters -
I'm not in favor of logos on clothing, but I like this one for the DIY utilitarian look.
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These are especially fitting, given that the Fourth of July is just days away... break out these babies and you'll definitely stand out, even among fireworks displays.
Added 6 Years Ago from Sockdreams -
Still want to show that American spirit but think that hats are a bit much??? Simple solution, a bowtie.
Added 6 Years Ago from Amazon.com


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African Dating in Kampala, Uganda
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"The harder you work, the luckier you get." by Gary Player
Below is the poem entitled Uncovering which was written by poet Sarah Myers. Please feel free to comment on this poem. However, please remember, PoetrySoup is a place of encouragement and growth.
Read Poems by Sarah Myers
Best Sarah Myers Poems
Unbearably I gaze through the endless smog, and attempt to blow clouds away. Though a pollution I have let it become, It seeps inside. Around, it is dark because inside so am I.


text:
jGuru Forums
Posted By: Nini_Khozeimeh Posted On: Friday, January 25, 2002 03:03 PM
Help! I have trie dto install java comm on my windows 2000 machine. i copies the files they said into the correct libraries and set the paths, but wheni compile it says that it cannot find the package javax.comm. Any help? Thanks. nini
Re: Java Comm
Posted By: B_V Posted On: Thursday, March 14, 2002 07:28 AM


text:
Spring Travel
Are You Traveling This Spring?
Like us on Facebook
When Spring is in the air, travel plans start emerging. According to an AOL travel survey, people are spending more this year on trips compared to last year. So travel is up according to poll results, but I'm wondering if this applies to you readers. Since travel is one of your favorite things to splurge on, I'm wondering if you're planning on embarking on a trip or if you're staying close to home?
Source: Thinkstock


text:
Open AccessThis article is
MDPI and ACS Style
- freely available
- re-usable
Sensors 2010, 10(4), 2626-2637; doi:10.3390/s100402626
Following Enzyme Activity with Infrared Spectroscopy
Received: 24 January 2010 / Revised: 20 February 2010 / Accepted: 6 March 2010 / Published: 25 March 2010
(This article belongs to the Special Issue Laser Spectroscopy and Sensing)
Abstract: Fourier transform infrared (FTIR) spectroscopy provides a direct, "on-line" monitor of enzymatic reactions. Measurement of enzymatic activity is based on the fact that the infrared spectra of reactants and products of an enzymatic reaction are usually different. Several examples are given using the enzymes pyruvate kinase, fumarase and alcohol dehydrogenase. The main advantage of the infrared method is that it observes the reaction of interest directly, i.e.,no activity assay is required to convert the progress of the reaction into an observable quantity.
vibrational spectroscopy; infrared spectroscopy; ATR; FTIR; enzyme activity
This is an open access article distributed under the
Creative Commons Attribution License which permits unrestricted use, distribution,
and reproduction in any medium, provided the original work is properly cited.
Export to BibTeX | EndNote
MDPI and ACS Style
Kumar, S.; Barth, A. Following Enzyme Activity with Infrared Spectroscopy. Sensors 2010, 10, 2626-2637.
AMA StyleKumar S, Barth A. Following Enzyme Activity with Infrared Spectroscopy. Sensors. 2010; 10(4):2626-2637.
Chicago/Turabian StyleKumar, Saroj; Barth, Andreas. 2010. "Following Enzyme Activity with Infrared Spectroscopy." Sensors 10, no. 4: 2626-2637.


text:
About the Between The Sheets Cocktail
This provocatively-named cocktail dates back to Prohibition and amps up the classic Sidecar formula with an extra glug of rum. Don't turn your back on the Between the Sheets—it may seem charming at first sip, but its double dose of spirits can easily sneak up on you.
Ingredients in the Between The Sheets Cocktail
- 1 oz Cognac
- 1 oz Triple sec
- 1 oz Light rum
- .25 oz Fresh lemon juice
Garnish: Flamed orange peel
Glass: Cocktail
How to make the Between The Sheets Cocktail
Add all the ingredients to a shaker and fill with ice. Shake, and strain into a chilled cocktail glass. Flame an orange peel over the glass and discard before serving.


text:
The number of deaths attributable to certain medical probes may go beyond a recent outbreak in Los Angeles.
The number of deaths attributable to certain medical probes may go beyond a recent outbreak in Los Angeles.
Evolving Ourselves, The Man Who Touched His Own Heart, Bats, and The Invaders.
Leonard Hayflick has been unafraid to speak his mind, whether it is to upend a well-entrenched dogma or to challenge the federal government. At 86, he's nowhere near retirement.
How to navigate the slings and arrows of conducting "controversial" research
Drug-resistant bacteria have spread in a Los Angeles hospital, perhaps from contaminated endoscopes.
Researchers document the bacterial life living among New York City's transit stations.
In the introduction to his latest book, author Melvin Konner explains why he considers maleness a departure from normal physiology.
Touch, The Altruistic Brain, Is Shame Necessary?, and Future Arctic
The era of human male domination is ending. Will modern culture welcome the dawn of a new gender equality?
Microorganisms continually challenge our assumptions of what life can achieve.


text:
Al Kehrer
Click here to view the item (new window) | |
Type: | photographic prints | StillImage | Image/jp2 |
Title: | Al Kehrer |
Date: | 1977 Jan. 26 |
Description: | Local identification number: L1983-26_1 Attached note: "1/26/77, To Al Kehrer, From Jim Wolfe, 'Testifying' at King Birthday Conference". |
Subjects: | Labor leaders--Southern States | United States |
Contributors: | Georgia State University. Libraries. Special Collections |
Online Publisher: | Special Collections and Archives, Georgia State University Library |
Original Material: | AFL-CIO Civil Rights Department, Southern Region Records, Southern Labor Archives |
Rights and Usage: | The contents of this item, including all images and text, are for personal, educational, and non-commercial use only. This item may be protected under United States and international copyright law. L1983-26_1, AFL-CIO Civil Rights Department, Southern Region Records Southern Labor Archives, Special Collections and Archives, Georgia State University, Atlanta. |
Persistent Link to Item: | http://digitalcollections.library.gsu.edu/cdm/ref/collection/labor/id/1767 |
Related Institutions: | Georgia State University. Libraries. Special Collections |
Collection Information: | Southern Labor Archives |


text:
Main Content
Oxford bibliographies. Philosophy [electronic resource] / editor in chief: Duncan Pritchard.
Access, holdings & availability
- Connect to resource.
Restricted for use by site license.
Record details
- Standardized title:
- Oxford Bibliographies.
- Other title:
- Philosophy
OBO Philosophy - Publication:
- Oxford : Oxford University Press
- Format/Description:
- Database/Website
Began in 2010. - Subjects:
- Philosophy -- Bibliography.
- System details:
- : Mode of access: World Wide Web.
- Summary:
- Offers peer-reviewed annotated bibliographies on philosophy. Bibliographies are browseable by subject area and keyword searchable. Contains a "My OBO" function that allows users to create personalized bibliographies of individual citations from different bibliographies.
- Notes:
- Description based on version viewed July 7, 2011; title from home page.
- Local notes:
- Acquired for the Penn Libraries with assistance from the Rev. C. P. Krauth Fund.
- Contributor:
- Pritchard, Duncan.
Oxford University Press.
Rev. C. P. Krauth Fund. - ISBN:
- 9780195396577 (OBO module)
019539657X (OBO module) - Web link:
- The Rev. C. P. Krauth Fund Home Page


text:
Baby I See You Working Hard
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The More If I Need To Reassure You, My Life Would Be Purposeless Without You
If I Want It (have It)
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What You Want To Eat Boo?
Let Me Feed You
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Do anything for my girl baby you blow me away
I Got Your Slippers, Your Dinner, Your Dessert, And So Much More
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Give My Breath, My Strength, My Will To you
That's the least I can do, let me cater to you
Cause your beautiful (your beautiful)
I love the way you are fulfill your every desire (desire)
Your wish is my command I wanna cater to my girl
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1 | This Grace |
2 | Worthy |
3 | Come As You Are |
4 | Mercy |
5 | You Came To My Rescue |
6 | Almighty |
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text:
Conference Addresses Animal Well-being issues
Internationally known scientists and industry leaders will gather at Purdue University April 27 to share the latest on new guidelines and research in farm animal well-being. "This past year has seen tremendous activity in the area of animal well-being," says Ed Pajor, conference organizer and Purdue assistant professor of animal sciences. The conference, "Animal Well-Being: Challenges and Strategies Towards Solutions," is sponsored by Purdue's Center for Food Animal Productivity and Well-Being and the United States Department of Agriculture/Agricultural Research Service's Livestock Behavior Research Unit located at Purdue. Targeted at agriculture and food industry leaders, the conference will focus on recent developments in animal well-being and the implications for animal agriculture in the future. Those present will share information and industry experiences in developing and implementing animal well-being guidelines, Pajor says. "This conference will feature the most recent scientific information on animal well-being, some of the issues involved and the latest thinking on the future of animal production practices," he says. Speakers discussing how the industry has implemented new animal well-being guidelines include Bob Langert, director of public and community affairs for McDonald's Corp.; Paul Sundberg of the National Pork Producers Council; Janet Riley of the American Meat Institute; Bob Krouse, chairman of the animal welfare committee for the United Egg Producers (UEP); and Joy Mench of the University of California Davis, who served on the UEP animal welfare committee. Talking about the historical and ethical context of animal well-being will be conference speakers David Fraser of the University of British Columbia and Paul Thompson, a bioethicist and director of the Purdue Center for Food Animal Productivity and Well-Being. Don Lay, USDA/ARS research unit leader, will share details about animal well-being research at Purdue. The conference runs from 8:30 a.m. to 5 p.m. in Stewart Center on Purdue's West Lafayette campus. Cost is $40 and does not include lunch. For registration information contact Donna Hufford in Purdue's Department of Animal Sciences at (765) 494-8007 or by e-mail at email@example.com. There is no registration deadline, but advance registration is preferred. More conference information is available at the Department of Animal Sciences' Web site at http://www.ansc.purdue.edu/events.htm.
Web Policies |


text:
FDA Approves Lymphoseek for Head and Neck Cancer »
"The U.S. Food and Drug Administration today approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic imaging agent used to help doctors determine the extent a type of cancer called squamous cell carcinoma"...
Read the FDA Approves Lymphoseek for Head and Neck Cancer article »
Patients receiving CeeNU should be given the following information and instructions by the physician:
- Patients should be told that CeeNU is an anticancer drug and belongs to the group of medicines known as alkylating agents.
- In order to provide the proper dose of CeeNU, patients should be aware that there may be 2 or more different types and colors of capsules in the container dispensed by the pharmacist.
- Patients should be told that CeeNU is given as a single oral dose and will not be repeated for at least 6 weeks.
- Patients should be told that nausea and vomiting usually last less than 24 hours, although loss of appetite may last for several days.
- If any of the following reactions occur, notify the physician: fever, chills, sore throat, unusual bleeding or bruising, shortness of breath, dry cough, swelling of feet or lower legs, mental confusion, or yellowing of eyes and skin.
- Patients should be told to wear gloves when handling CeeNU Capsules.
Last reviewed on RxList: 6/16/2011
This monograph has been modified to include the generic and brand name in many instances.
CeeNU FDA Prescribing Information
Additional CeeNU Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.


text: DIY Idea: Easy Modern Centerpieces from Frolic March 23, by Kimberly Jones. Leave a CommentThis modern take on wrapping books in paper adds a pop of color to wedding centerpieces! Chelsea from Frolic shares the instructions at Delightfully Engaged here. Related Posts:Neon Polka Dotted Wedding FavorsEasy Herbal Centerpieces21 Easy DIY Centerpieces for Fall & Winter Weddings{Monday Moods at DIY Weddings} Modern Rainbow{Modern Wedding Inspiration} DIY PumpkinsShare this:Share on FacebookClick to share on PinterestClick to email this to a friendClick to share on StumbleUponClick to share on TwitterClick to share on Google+


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- 3 weeks ago by Heather Cichowski
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