CFR section
21 CFR 600.80(b): Postmarketing reporting of adverse experiences
PART 600-BIOLOGICAL PRODUCTS: GENERAL · Subpart D-Reporting of Adverse Experiences
Key facts
| Citation | 21 CFR 600.80(b) |
|---|---|
| Section | Postmarketing reporting of adverse experiences |
| Part | PART 600-BIOLOGICAL PRODUCTS: GENERAL |
| Subpart | Subpart D-Reporting of Adverse Experiences |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs |
| Regulation text (excerpt) | (b) Review of adverse experiences. Any person having a biologics license under § 601.20 of this chapter must promptly review all adverse experience information pertaining to its product obtained or otherwise received by the applicant from any source, foreign or domestic, including information derived from commercial marketing experience, postmarketing clinical investigations, postmarketing epidemiological/surveillance studies, reports in the scientific literature, and unpublished scientific… |
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