CFR section
21 CFR 314.81(b)(1)(i): Other postmarketing reports
PART 314-APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG · Subpart B-Applications
Key facts
| Citation | 21 CFR 314.81(b)(1)(i) |
|---|---|
| Section | Other postmarketing reports |
| 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) | (i) Information concerning any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article. |
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.