CFR section
21 CFR 600.80(c)(2)(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)(2)(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 |
| Regulation text (excerpt) | (ii) Each periodic report is required to contain: (A) Descriptive information. (1) A narrative summary and analysis of the information in the report; (2) An analysis of the 15-day Alert reports submitted during the reporting interval (all 15-day Alert reports being appropriately referenced by the applicant's patient identification code for nonvaccine biological product reports or by the unique case identification number for vaccine reports, adverse reaction term(s), and date of submission to… |
At a glance
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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.