CFR section
21 CFR 314.80(f)(2): 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(f)(2) |
|---|---|
| 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 |
| Regulation text (excerpt) | (2) Adverse drug experience. (i) Outcome attributed to adverse drug experience; (ii) Date of adverse drug experience; (iii) Date of ICSR submission; (iv) Description of adverse drug experience (including a concise medical narrative); (v) Adverse drug experience term(s); (vi) Description of relevant tests, including dates and laboratory data; and (vii) Other relevant patient history, including preexisting medical conditions. |
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.