FDA releases final Guidance for Industry and FDA Staff on Postmarketing Safety Reporting for Combination Products

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-safety-reporting-combination-products?utm_campaign=FDA%20reinforces%20need%20for%20applicants%20to%20submit%20thorough%20and%20timely%20-%20Drug%20Information%20Update&utm_medium=email&utm_source=Eloqua

FDA releases final Guidance for Industry and FDA Staff on Postmarketing Safety Reporting for Combination Products

The U.S. Food and Drug Administration released a final guidance, “Postmarketing Safety Reporting for Combination Products,” for applicants of combination products—products composed of two or more different types of medical products (i.e., drug, device or biologic)—to further clarify how they can comply with the 2016 final rule on postmarketing safety reporting requirements (PMSR) for combination products.

For more information, please visit: FDA In Brief.