Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
Posted 25 May 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted on 24 May to partially support Pfizer's drug, tafamadis, which is looking for FDA approval to treat a rare neurodegenerative disease.
The panel voted 13 to 4 against the drug in an initial vote, saying study data did not show the drug to be effective in directly slowing the progression of familial amyloid polyneuropathy (FAP). The committee later voted again, finding in a 13 to 4 decision that tafamadis was effective in treating surrogate endpoints associated with FAP such as limb function.
The split vote may spell trouble of tafamadis at FDA, reports Reuters, as its staff "recommended rejecting the drug saying the data did not prove that it worked well in treating the disease." Those concerns are likely to be weighed against the needs of the approximately 2,500 US patients suffering from FAP who currently lack medicinal options to treat the disorder, reports Med Page Today.
The drug is already approved by the European Medicines Agency (EMA) for the condition, and is marketed under the trade name Vyndaqel.
Reuters - U.S. panel split on Pfizer rare disease drug
Med Page Today - FDA Panel Sends Mixed Message on Pfizer Drug
PMLiVE - FDA panel supports Pfizer's tafamidis despite efficacy concerns
The Pink Sheet Daily - Pfizer's Vyndaqel Splits Advisory Committee; Now It Must Move FDA
Tags: CNSDAC, Vyndaqel, Tafamadis, FAP, Pfizer, CNS, AdComm, Latest News, advisory committee
Regulatory Focus newsletters
All the biggest regulatory news and happenings.