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20 October 2020
The International Medical Device Regulators Forum has issued a proposed update to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices, with advice on the design, implementation, and appropriate use of these studies.  

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20 October 2020
A new draft guidance related to postmarketing requirements and commitments is available from the US Food and Drug Administration (FDA). The document details how drug and biologics marketers will use two forms for online submission of annual status...
20 October 2020
With less than two months remaining before the Eudamed actor registration module goes live, the European Commission on Tuesday posted a new webpage explaining the steps necessary for actors to register for the database.
19 October 2020
Medicines containing the diabetes medication metformin must be tested for the presence of nitrosamines before being released into the European Market, said a committee of the European Medicines Agency (EMA) following its scheduled September meetin...
19 October 2020
Data integrity issues and “pandemic-induced protocol deviations” are a concern for oncology trial sponsors and FDA alike, and the agency has been attempting to be as flexible as is possible while safeguarding patient wellbeing and clinical trial i...
19 October 2020
Surgical staplers and laparoscopic power morcellators are among devices that made the grade for the US Food and Drug Administration’s (FDA’s)slate of final guidance topics for fiscal year 2021. The agency also plans to draft a transition plan for ...
16 October 2020
Two new pilot programs related to manufacturing quality management have been launched by the US Food and Drug Administration (FDA).