Draft Guidance for Industry and Reviewers on How the Center for Veterinary Medicine Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability for comment of a draft guidance for industry and reviewers (#119) entitled "How the Center for Veterinary Medicine Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug." This draft guidance is neither final nor is it in effect at this time. This draft guidance announces the Center for Veterinary Medicine's (CVM) policy regarding the circumstances under which CVM intends to discontinue review of submissions filed during the investigation of a new animal drug, notify the sponsor that review has been discontinued, and remove the submission from the queue.