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GUIDANCE DOCUMENT

CVM GFI #119 How CVM Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug August 2002

Final
Docket Number:
FDA-2001-D-0011
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

CVM’s Office of New Animal Drug Evaluation (ONADE) encourages sponsors to submit data, study protocols, or other information for review at the most appropriate and productive times in the drug development process rather than submitting all data at one time in a New Animal Drug Application (NADA). Thus, sponsors may submit data intended to support an application for new animal drug approval during the investigation of the new animal drug to an investigational new animal drug (INAD) file.

This guidance announces CVM’s policy regarding the circumstances under which ONADE intends to notify the sponsor that its submission relating to a new animal drug approval (filed to the INAD file) will not be accepted for review and remove the submission from the review queue.


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-2001-D-0011.

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