CFR section
21 CFR 314.81(b)(2)(vii): 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)(2)(vii) |
|---|---|
| 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) | (vii) Status reports of postmarketing study commitments. A status report of each postmarketing study of the drug product concerning clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology that is required by FDA (e.g., accelerated approval clinical benefit studies, pediatric studies) or that the applicant has committed, in writing, to conduct either at the time of approval of an application for the drug product or a supplement to an application, or after approval of… |
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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.