CFR section
21 CFR 600.80(c)(1)(ii): 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)(ii) |
|---|---|
| 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, Devices, Drugs |
| Regulation text (excerpt) | (ii) Postmarketing 15-day “Alert reports”-followup. The applicant must promptly investigate all adverse experiences that are the subject of these postmarketing 15-day Alert reports and must submit followup reports within 15 calendar days of receipt of new information or as requested by FDA. If additional information is not obtainable, records should be maintained of the unsuccessful steps taken to seek additional information. |
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About CFR sections cited by the FDA
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.