Post-marketing Safety Reporting for Combination Products

FDA issued the final guidance for industry and FDA staff on July 22, 2019

This guidance addresses certain ways to comply with the final rule on post-marketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603) and that is codified in 21 CFR Part 4, Subpart B (hereafter the “combination product PMSR final rule,” “final rule,” or “rule”). Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct reporting requirements, including reporting triggers and timeframes. The rule addresses PMSR requirements for combination products that have received FDA marketing authorization, to ensure consistent and complete reporting while avoiding duplication.

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