RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization.

Stay informed on the latest healthcare regulatory news through RAPS’ online magazine, Regulatory Focus and its companion daily e-newsletter RF Today, or by following RAPS on social media, including TwitterLinkedIn and Facebook.

Reporters, bloggers and other members of the media interested in covering RAPS events or programs should contact Nicole Duran, senior manager of communications, at nduran@raps.org or by calling +301 770 2920 ext. 245.

Press Releases

Announcing an improved online community for RAPS members

Posted 29 November 2022 | By

The same community RAPS members have come to rely on, now with a sleeker look.

RAPS launches Spanish network and debuts reinvigorated Irish association

Posted 02 November 2022 | By

These moves mark another step in RAPS’ mission to unite the global regulatory community in education, knowledge-sharing and career development. With the addition of Spain, RAPS now boasts 31 ...

RAPS and Pathway for Patient Health team up to bolster regulatory education

Posted 19 October 2022 | By

RAPS and Pathway for Patient Health have partnered to advance the preparedness of regulatory affairs professionals during an unparalleled time of rapid innovation and evolving expectations.

RAPS congratulates 82 professionals for earning RAC certification

Posted 10 October 2022 | By

RAPS congratulates the 82 professionals who earned their Regulatory Affairs Certification (RAC) during the summer examination window. The RAC credential is the leading certification for regula...

1,700 Gather in Phoenix for RAPS Convergence 2022

Posted 13 September 2022 | By

The Regulatory Affairs Professionals Society (RAPS) concluded its annual RAPS Convergence in Phoenix on Tuesday, 13 September, attracting 1,700 participants from 41 countries across five conti...

RAPS in the News

Dearth of Participation From Black Patients Noted in CAR T Clinical Trials Supporting FDA Approvals | Cancer Network

Posted 09 May 2022 | By Ariana Pelosci

Investigators identified that in pivotal clinical trials supporting FDA approvals of CAR T-cell therapies for patients with hematologic cancer, Black patients were significantly underrepresented.

MedCon: Industry praises FDA’s digital health Pre-Cert pilot | Hebdenbridge News

Posted 06 May 2022

Stakeholders in a session at MedCon 2022 expressed largely positive sentiments about their experience with the US Food and Drug Administration’s (FDA) Digital Health Software Precertification (Pre-Cert) Program.

FDA Draft Guidance Would Set In Stone Case For Quality Voluntary Improvement Program | MedTech Insight

Posted 05 May 2022 | By Shawn M. Schmitt

The draft document from the US agency looks to officially recognize a program aimed at advancing quality in medical devices and their manufacturing.

FDA loosens review process for certain orthopedic devices | Becker's Spine Review

Posted 12 April 2022 | By Alan Condon

The FDA has issued two guidelines that make it less complex for medtech companies to commercialize orthopedic devices and sutures using its safety and performance-based pathway, according to the Regulatory Affairs Professionals Society.