CFR section
21 CFR 329.100(c)(1): Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act
PART 329-NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
Key facts
| Citation | 21 CFR 329.100(c)(1) |
|---|---|
| Section | Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act |
| Part | PART 329-NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs |
| Regulation text (excerpt) | (1) Each report required to be submitted to FDA under section 760 of the FD&C Act, accompanied by a copy of the label on or within the retail package of the drug and any other documentation (as ICSR attachments), must be in an electronic format that FDA can process, review, and archive. FDA will issue guidance on how to provide the electronic submission (e.g., method of transmission, media, file formats, preparation, and organization of files). |
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.