CFR section
21 CFR 514.80(b)(2)(i): 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)(2)(i) |
|---|---|
| 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, Veterinary |
| Regulation text (excerpt) | (i) Initial report. This report provides information on each serious, unexpected adverse drug event, regardless of the source of the information. The applicant (or nonapplicant through the applicant) must submit the report to FDA within 15 working days of first receiving the information. The report must be submitted to FDA in electronic format as described in paragraph (d)(1) of this section, unless the applicant obtains a waiver under paragraph (d)(2) of this section or FDA requests the report… |
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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.