Regulatory Affairs Professionals Society

@RAPSorg

The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the healthcare products sector.

Rockville, MD, USA RAPS.org Joined February 2010

1.2K Following 12K Followers 33K Posts

Latest posts 5

Regulatory Affairs Professionals Society @RAPSorg 3d

A FDA official stated that the midterm congressional election results will not likely impact the reauthorization of the agency’s user fee agreements, which have been negotiated for FY 2028-2032.

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www.raps.org FDA official expects user fee reauthorization despite midterm shakeup BETHESDA, MD – A top US Food and Drug Administration (FDA) official stated that the midterm congressional election results will not likely impact the reauthorization of the agency’s user fee agreem...

Regulatory Affairs Professionals Society @RAPSorg 3d

As artificial intelligence (AI) permeates the regulatory world, experts said it won't take over regulatory professionals' jobs but will instead help them work more efficiently and dedicate more time on human interactions.

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www.raps.org AI won’t erase jobs, but regulatory professionals need to be vigilant, experts say BARCELONA – As artificial intelligence (AI) permeates the regulatory world, experts said it won't take over regulatory professionals' jobs but will instead help them work more efficiently and...

Regulatory Affairs Professionals Society @RAPSorg 4d

Sarah Yim, director of the FDA Office of Therapeutic Biologics and Biosimilars in the Office of New Drugs, emphasized that the agency is actively working to help sponsors reduce their reliance on clinical efficacy studies.

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www.raps.org FDA official urges sponsors to use alternatives to clinical efficacy studies for biosimilars BETHESDA, MD – Sarah Yim, director of the US Food and Drug Administration’s (FDA) Office of Therapeutic Biologics and Biosimilars in the Office of New Drugs, emphasized that the agency is actively...

Regulatory Affairs Professionals Society @RAPSorg 5d

A top US FDA enforcement official announced that the agency conducted more unannounced drug inspections in India and China in FY 2026 compared to the previous year.

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www.raps.org FDA unannounced foreign inspections in China and India increased in FY 2026 BETHESDA, MD – A top US Food and Drug Administration (FDA) enforcement official announced that the agency conducted more unannounced drug inspections in India and China in FY 2026 compared to the...

Regulatory Affairs Professionals Society @RAPSorg 5d

More than 500 comments have been submitted in response to the FDA discussion paper on generative AI (genAI)-enabled medical devices, and stakeholders have offered the agency a wide variety of advice on the best way to regulate these technologies.
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www.raps.org GenAI: Stakeholders offer competing views on FDA's regulatory approach More than 500 comments have been submitted in response to the US Food and Drug Administration’s (FDA) discussion paper on generative AI (genAI)-enabled medical devices, and stakeholders have offered...