CFR section
21 CFR 511.1(b)(8)(iv): 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)(iv) |
|---|---|
| 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 | Veterinary |
| Regulation text (excerpt) | (iv) Shall not, nor shall any person acting for or on behalf of the sponsor, represent that the new animal drug is safe or effective for the purposes for which it is under investigation. This requirement is not intended to restrict the full exchange of scientific information. |
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