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 raps@raps.org if you need assistance.
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.
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.
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.
Posted 18 October 2012 | By Alexander Gaffney, RAC,
What did the US Food and Drug Administration (FDA) know, and when did it know it? That's the question being asked of agency officials this week as legislators with the House Energy and Commerce (E&C) Committee sent FDA a letter asking for all details regarding its oversight of a compounding pharmacy.
The E&C Committee is in the midst of investigating the New England Compounding Center, which has been linked to a massive outbreak of meningitis that has thus far killed 19 patients and sickened hundreds in dozens of states around the US. Federal officials, including those at FDA, the Center for Disease Control and Prevention (CDC) and the Drug Enforcement Administration (DEA) have been scrambling to track patients and secure supplies of all drugs manufactured at the pharmacy, some of which are contaminated with fungal meningitis.
The letter requests, "All documents related to FDA's oversight of the NECC dating back to 2004"-a marked escalation in the scope and depth of details sought by the committee. Previously, members of the committee had asked for summary information regarding the agency's activities and whether it required additional authority to regulate compounding pharmacies such as NECC.
In their 17 October letter to FDA Commissioner Margaret Hamburg, E&C Chairman Fred Upton (R-MI) and Ranking Member Henry Waxman (D-CA) called for three specifics from FDA: all inspection reports and records pertaining to NECC, all communications between NECC or the Massachusetts Board of Registration in Pharmacy or other inspectors and all information about briefings with individuals in the Office of the Commissioner about NECC.
The letter could mark the start of an investigation into FDA's handling of NECC. The representatives noted FDA had issued a warning letter to NECC in 2006 after a two-year-long investigation into its manufacturing facility.
Upton and Waxman said they were troubled by FDA's inability to, "Confirm whether any subsequent inspections were conducted to validate that the Food, Drug and Cosmetic Act violations [identified in the warning letter] were corrected."
Tags: Crisis, Meningitis, Legislators, Compounding, Upton, Waxman, Letter, Scandal, Latest News, Congress
Regulatory Focus newsletters
All the biggest regulatory news and happenings.