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 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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 24 July 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) has been ordered by a federal judge to release thousands of documents to an attorney representing former employees of the agency who now allege they were the subject of an illegal surveillance program.
Judge James Boasberg of the District Court of DC sided with the National Whistleblowers Center (NWC) at the 23 July hearing, and has ordered the agency to turn over more than 4,000 pages of documents related to the case to NWC by 24 August. All other documents will have to be made available by 10 September, notes Bloomberg Businessweek.
The initial materials are to be made available more quickly in the interest of expediency, added Bloomberg.
FDA's case may have been made more difficult after The New York Times discovered nearly 80,000 documents related to the case posted online by a contractor for the agency. Bloomberg notes that the information ordered released by the judge today doesn't include information accidentally released by FDA.
As the NWC's motion is also a Freedom of Information Act request, it remains likely that the request will eventually be made public, either by the agency or other parties.
As Regulatory Focusreported on 16 July, the NWC filed a lawsuit on behalf of the whistleblowers in May 2012 seeking to compel FDA to turn over "records concerning the warrantless surveillance program and to complete the processing of the documents within 40 days."
(For background information, please see Regulatory Focus' 16 July story, "Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices")
While the group's Motion for Preliminary Injunction was originally set to be heard by the US District Court of DC on 21 June, the case was pushed back until 23 July for unknown reasons.
The motion was the third lawsuit filed by NWC against FDA, with the first two lawsuits meeting with more limited success.
Read more:
Tags: NWC, FOIA, Whistleblowing, Surveillance, FDA Nine, Lawsuit, Court, Latest News
Regulatory Focus newsletters
All the biggest regulatory news and happenings.