CFR section
21 CFR 310.305(c)(1)(i): 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)(1)(i) |
|---|---|
| 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, General |
| Regulation text (excerpt) | (i) Any person whose name appears on the label of a marketed prescription drug product as its manufacturer, packer, or distributor must report to FDA each adverse drug experience received or otherwise obtained that is both serious and unexpected as soon as possible, but no later than 15 calendar days from initial receipt of the information by the person whose name appears on the label. Each report must be accompanied by the current content of labeling in electronic format as an ICSR attachment… |
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.