CFR section
21 CFR 310.305(c)(2): Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications
PART 310-NEW DRUGS · Subpart D-Records and Reports
Key facts
| Citation | 21 CFR 310.305(c)(2) |
|---|---|
| Section | Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications |
| Part | PART 310-NEW DRUGS |
| Subpart | Subpart D-Records and Reports |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs |
| Regulation text (excerpt) | (2) Postmarketing 15-day “Alert reports”-followup. Each person identified in paragraph (c)(1)(i) of this section must promptly investigate all serious, unexpected adverse drug 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… |
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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.