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 email@example.com 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 26 March 2012 | By Alexander Gaffney, RAC
A unanimous decision last week by the Supreme Court of the United States (SCOTUS) against the US Environmental Protection Agency (EPA) could place warnings letters sent by the US Food and Drug Administration (FDA) into a quagmire of litigation, report various sources.
In Sackett v. EPA, SCOTUS ruled the Administrative Procedure Act-the act governing how FDA and other federal agencies create regulations and make decisions-did not preclude the litigants from immediately challenging EPA compliance orders.
While the ruling rejected Sackett's arguments that the orders-similar to FDA warning letters-violated Sackett's due process rights under the constitution, the ruling could mire future warning letters in a sea of litigation, writes Nina Mendelson of the Center for Progressive Reform.
"[EPA] may use compliance orders less often and when it does use them, it may take much longer for the orders to go into effect," concludes Mendelson.
Center for Progressive Reform - SCOTUS Decision in Sackett v. EPA Weakens Government's Ability to Respond to Urgent Threats to Water Quality
The Pink Sheet Daily - FDA Warning Letters Could Face Litigation In Wake Of Supreme Court's EPA Ruling
Center for Progressive Reform - After Sackett: What Next for Administrative Compliance Orders?
Penn Program on Regulation - Opinion: Rule of Law Prevails in Sackett v. EPA
Tags: Administrative Procedure Act, Sackett v. EPA, EPA, Justice, warning letter, SCOTUS, Law, Latest News, decision, warning letters
Regulatory Focus newsletters
All the biggest regulatory news and happenings.