CFR section
21 CFR 310.305(d)(1): 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(d)(1) |
|---|---|
| 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, Food/Cosmetics |
| Regulation text (excerpt) | (1) Patient information. (i) Patient identification code; (ii) Patient age at the time of adverse drug experience, or date of birth; (iii) Patient gender; and (iv) Patient weight. |
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.