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GUIDANCE DOCUMENT

CVM GFI #132 Administrative Applications and the Phased Review Process May 2018

Final
Docket Number:
FDA-2002-D-0147
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance defines:

  1. the “phased review process” for reviewing application-level information during the investigational period of new animal drug development, and
  2. 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.

Submit Comments

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:

Dockets Management
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.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002