- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This document provides guidance to industry on the development of decorporation agents for which evidence is needed to demonstrate effectiveness but for which human efficacy studies are unethical or infeasible. In such instances, the Animal Efficacy Rule, 21 CFR part 314 subpart I, may be invoked to approve new decorporation agents not previously marketed or new indications for previously marketed drug products. Specifically, this document provides guidance on (1) chemistry, manufacturing, and controls (CMC) information; (2) animal efficacy, safety pharmacology, and toxicology studies; (3) clinical pharmacology, biopharmaceutics, and human safety studies; and (4) postapproval commitments, for such drug products.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2005-D-0025.