CFR section
21 CFR 514.80(a)(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(a)(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 | Veterinary |
| Regulation text (excerpt) | (1) Each applicant must establish and maintain indexed and complete files containing full records of all information pertinent to safety or effectiveness of a new animal drug that has not been previously submitted as part of the NADA or ANADA. Such records must include information from domestic as well as foreign sources. Each nonapplicant must establish and maintain indexed and complete files containing full records of all information pertinent to safety or effectiveness of a new animal drug… |
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