CFR section
21 CFR 314.81(b)(2)(vii)(a): 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)(a) |
|---|---|
| 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) | (a) Content of status report. The following information must be provided for each postmarketing study reported under this paragraph: (1) Applicant's name. (2) Product name. Include the approved drug product's established name and proprietary name, if any. (3) NDA, ANDA, and supplement number. (4) Date of U.S. approval of NDA or ANDA. (5) Date of postmarketing study commitment. (6) Description of postmarketing study commitment. The description must include sufficient information to uniquely… |
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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.