FDA Guidance for Industry: Postmarketing Safety Reporting for Combination Products
Title:
FDA Guidance for Industry: Postmarketing Safety Reporting for Combination Products
Origin/Publisher:
FDA
Content:
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”).