CFR section
21 CFR 600.80(c)(2)(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)(2)(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 |
| Regulation text (excerpt) | (i) The applicant must report each adverse experience not reported under paragraph (c)(1)(i) of this section at quarterly intervals, for 3 years from the date of issuance of the biologics license, and then at annual intervals. The applicant must submit each quarterly report within 30 days of the close of the quarter (the first quarter beginning on the date of issuance of the biologics license) and each annual report within 60 days of the anniversary date of the issuance of the biologics license… |
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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.