CFR section
21 CFR 314.81(b)(2)(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)(2)(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) Summary. A brief summary of significant new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product. The report is also required to contain a brief description of actions the applicant has taken or intends to take as a result of this new information, for example, submit a labeling supplement, add a warning to the labeling, or initiate a new study. The summary shall briefly state whether labeling supplements for pediatric use have been… |
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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.