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

Issue Date: August 29, 2002
Issued by: Center for Veterinary Medicine
Topic(s): Investigational New Animal Drug (INAD)
Status: Final

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

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.

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