CVM GFI #132 Administrative Applications and the Phased Review Process May 2018
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary Medicine
This guidance defines:
- the “phased review process” for reviewing application-level information during the investigational period of new animal drug development, and
- an “administrative” new animal drug application (NADA) or abbreviated new animal drug application (ANADA), the content, the procedures a sponsor should follow to submit such an application, and the intended time frame for its review.
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-2002-D-0147.