CFR section
21 CFR 314.98(b): Postmarketing reports
PART 314-APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG · Subpart C-Abbreviated Applications
Key facts
| Citation | 21 CFR 314.98(b) |
|---|---|
| Section | Postmarketing reports |
| Part | PART 314-APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG |
| Subpart | Subpart C-Abbreviated Applications |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (b) Each applicant must make the reports required under § 314.81 and section 505(k) of the Federal Food, Drug, and Cosmetic Act for each of its approved abbreviated applications. |
At a glance
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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.