CFR section
21 CFR 511.1(b)(8)(ii): New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act
PART 511-NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
Key facts
| Citation | 21 CFR 511.1(b)(8)(ii) |
|---|---|
| Section | New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act |
| Part | PART 511-NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE |
| Subchapter | 21 CFR E Drugs Animal |
| Product types cited | General, Veterinary |
| Regulation text (excerpt) | (ii) Shall provide for current monitoring of the investigation by a person qualified by scientific training and experience to evaluate information obtained from the investigation, and shall promptly investigate and report to FDA and to all investigators any findings associated with use of the new animal drug that may suggest significant hazards pertinent to the safety of the new animal drug. |
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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.