Assessment of Abuse Potential of Drugs
CDER 2016-69 Assessment of Abuse Potential of Drugs
2020-06-01 2010-03-29 2010-03-24 2010-03-30 2010-03-24 2020-06-01 2021-07-19
FDA-2010-D-0026-0031 FDA-2010-D-0026-0011 FDA-2010-D-0026-0005 FDA-2010-D-0026-0018 FDA-2010-D-0026-0006 FDA-2010-D-0026-0032 FDA-2010-D-0026-0033
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0031 https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0011 https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0005 https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0018 https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0006 https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0032 https://api.regulations.gov/v4/comments/FDA-2010-D-0026-0033
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
You all are the worst - yall are making the world suffer and causing people to commit suicide because of pain that goes untreated because you all insist of causing torment across the country due to 2% of problem users. I hope our families disown you all for you actions against our most vulnerable. Yall all no better than terrorist who pray on the weak. Punks. Im an inventor for our countrys citizens and I wish you all would wake up and start making rational, logical decisions. Dont punish pain, punish yourselves for the torment youve all caused to our most vulnerable Citizens.  The Pharmaceutical Research and Manufacturers of America (PhRMA) is pleased to provide comments on the above-noted draft guidance.  PhRMA is a voluntary, non-profit trade organization representing the firms that discover, develop and produce prescription drugs and biologic products. In 2009, Americas pharmaceutical research and biotechnology companies invested $65.3 billion in the research and development of new life-changing medicines. PhRMA-member companies alone invested over $45 billion in research and development leading to new cures.  PhRMA appreciates FDAs efforts in drafting guidance for assessment of abuse potential of drugs.  This is a constructive step and will assist sponsors who are developing drugs and other medical products with the potential for abuse that may need to be scheduled under the Controlled Substances Act.The new draft guidance provides information on submitting an abuse potential assessment, including a proposal for scheduling and information for sponsors performing an assessment, including (1) the design and conduct of appropriate studies and investigations and (2) general administrative recommendations for submitting a proposal for scheduling.A PhRMA team with experience in abuse liability management was assembled and has reviewed the draft guidance and is pleased to take this opportunity to provide comments. Our intention is to assist the FDA in developing guidance that clearly outlines current expectations for assessing new medicines for abuse liability potential.  We believe the current draft guidance can be enhanced with additional details which help to address the complexities associated with this topic.  PhRMA believes that differing approaches to assessing drug abuse potential are appropriate given the variety of molecules (large and small) and pharmacological classes (known abuse; no known abuse; novel mechanism of action) which exist. Comments of The College on Problems of Drug Dependence (CPDD), submitted by Patrick M. Beardsley, Ph.D., on behalf of Linda Porrino, Ph.D., President of CPDD. This file contains our comments on the Draft Guidance for Industry on Assessment of Abuse Potential of Drugs. Comments on the Draft Guidance for Industry on Assessment of Abuse Potential of Drugs from Pinney Associates Let people make their own decisions, this is the job of us the citizenry, leave us alone and let us treat ourselves for the problems we have, not the FDA or DEA. its our lives, and we should have all choices available to us (even diamorphine). We need to follow  Portugal. we are failing our country by controlling people who are suffering. its cruel and unusual punishment. Im an inventor and want the best for our country and that starts by people making their own decisions, not have anouther human or organization make it for us. People are dying because of how you treat our country.  My name is Dr. Elan Cohen and I work at a research site in the US where I am a PI. We conduct Human Abuse Liability / Potential (HAL/P) studies and I wanted to ask a few questions about our work on these clinical trials from someone in the FDA who reviews / approves these trials. Please, how do I talk or have an email exchange from someone at the FDA who reviews drugs using the Assessment of Abuse Potential of Drugs Guidance or who approves/reviews HAL/P studies? My email is ecohen@hritrials.com and my cell is 267-981-8911. My questions are not about reporting any maleficent behavior; just questions about the conduct of such trials. Thank you for any help you can provide in having such an FDA personnel contact me. Elan Cohen  