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17 October 2019
The US Department of Health and Human Services’ Office of Inspector General (OIG) will issue a report next year on the US Food and Drug Administration’s (FDA) postmarket surveillance of medical devices, which has come under fire in recent months.

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17 October 2019
Drugmakers and industry groups are calling on the US Food and Drug Administration (FDA) to expand and clarify its recent draft guidance on how to use its inactive ingredient database (IID).
17 October 2019
The Belgian Competition Authority (BCA) said recently that it’s inspecting the premises of companies suspected of using restrictive practices to limit, delay or prevent the entry of biosimilar competition.
17 October 2019
The European Commission’s Medical Device Coordination Group (MDCG) on Thursday released a final assessment form for authorities designating conformity assessment bodies (CABs) and notified bodies (NBs) under the EU Medical Devices Regulation (MDR)...
17 October 2019
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday alerted to a recall of its heartburn medicine ranitidine following similar recalls due to possible contamination with an impurity called NDMA (N-nitrosodimethylamine),...
17 October 2019
Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.
17 October 2019
RAPS has announced the official launch of the RAPS Colorado Chapter. Chapter leaders and other representatives attended RAPS’ recent Regulatory Convergence in Philadelphia, where they were welcomed and acknowledged by RAPS Executive Director Paul ...