Final 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 of a final 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 final guidance announces the Center for Veterinary Medicine's (CVM's) policy regarding the circumstances under which CVM intends to not accept for review submissions filed during the investigation of a new animal drug and notify the sponsor that CVM intends not to review the submission.