CFR section
21 CFR 514.80(b)(2)(ii): 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)(ii) |
|---|---|
| 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) | (ii) Followup report. The applicant must promptly investigate all adverse drug events that are the subject of 15-day NADA/ANADA alert reports. If this investigation reveals significant new information, a followup report must be submitted within 15 working days of receiving such information. A followup 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… |
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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.