CFR section
21 CFR 314.80(c)(2)(ii)(A): Postmarketing reporting of adverse drug experiences
PART 314-APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG · Subpart B-Applications
Key facts
| Citation | 21 CFR 314.80(c)(2)(ii)(A) |
|---|---|
| Section | Postmarketing reporting of adverse drug experiences |
| Part | PART 314-APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG |
| Subpart | Subpart B-Applications |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (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, adverse reaction term(s), and date of submission to FDA); (3) A history of actions taken since the last report because of adverse drug experiences (for example, labeling changes or studies initiated); and (4) An… |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
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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.