CFR section
21 CFR 514.80(b)(4)(iv)(B): 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)(4)(iv)(B) |
|---|---|
| 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 | Veterinary |
| Regulation text (excerpt) | (B) Reports of adverse drug experiences in the literature must be noted in the periodic drug experience report. A bibliography of pertinent references must be included with the report. Upon FDA's request, the applicant must provide a full text copy of these publications. |
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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.