CFR section
21 CFR 310.305(a): Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications
PART 310-NEW DRUGS · Subpart D-Records and Reports
Key facts
| Citation | 21 CFR 310.305(a) |
|---|---|
| Section | Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications |
| Part | PART 310-NEW DRUGS |
| Subpart | Subpart D-Records and Reports |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs |
| Regulation text (excerpt) | (a) Scope. FDA is requiring manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiences associated with the use of their drug products. Any person subject to the reporting requirements of paragraph (c) of this section must also develop written procedures for the surveillance, receipt… |
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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.