CFR section
21 CFR 511.1(b)(4): 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)(4) |
|---|---|
| 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) | (4) Prior to shipment of the new animal drug for clinical tests in animals, the sponsor of the investigation shall submit in triplicate to FDA a “Notice of Claimed Investigational Exemption for a New Animal Drug” including a signed statement containing the following information: (i) The identity of the new animal drug. (ii) All labeling and other pertinent information to be supplied to the investigators. When such pertinent information includes nonclinical laboratory studies, the information… |
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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.