CFR section
21 CFR 514.80(b)(1): Records and reports concerning experience with approved new animal drugs
PART 514-NEW ANIMAL DRUG APPLICATIONS · Subpart B-Administrative Actions on Applications
Key facts
| Citation | 21 CFR 514.80(b)(1) |
|---|---|
| Section | Records and reports concerning experience with approved new animal drugs |
| Part | PART 514-NEW ANIMAL DRUG APPLICATIONS |
| Subpart | Subpart B-Administrative Actions on Applications |
| Subchapter | 21 CFR E Drugs Animal |
| Product types cited | Drugs, Food/Cosmetics, Veterinary |
| Regulation text (excerpt) | (1) Three-day NADA/ANADA field alert report. This report provides information pertaining to product and manufacturing defects that may result in serious adverse drug events. The applicant (or nonapplicant through the applicant) must submit the report to the appropriate FDA District Office or local FDA resident post within 3 working days of first becoming aware that a defect may exist. The information initially may be provided by telephone or other telecommunication means, with prompt written… |
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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.