CFR section
21 CFR 600.80(c)(1)(i): Postmarketing reporting of adverse experiences
PART 600-BIOLOGICAL PRODUCTS: GENERAL · Subpart D-Reporting of Adverse Experiences
Key facts
| Citation | 21 CFR 600.80(c)(1)(i) |
|---|---|
| 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) | (i) Postmarketing 15-day “Alert reports”. The applicant must report each adverse experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but no later than 15 calendar days from initial receipt of the information by the applicant. |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.