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FDA Guidance for Industry: Postmarketing Safety Reporting for Combination Products



This guidance addresses certain ways to comply with the final rule on postmarketing safety1, 2 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”).

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