January 01, 2003


 FDA advises drug sponsors on supplemental drug applications

Posted Dec. 15, 2002

The Food and Drug Administration has released final guidance to educate sponsors of new animal drug applications regarding the development of supplemental applications.

The document,"Development of Supplemental Applications for Approved New Animal Drugs" (GL #82), explains how and when drug sponsors may use data collected for original NADAs to support the technical sections of a supplemental NADA. It also explains when the FDA-CVM may, under existing statutes or regulations, require submission of new data. Finally, the guidance delineates the instances in which a sponsor will generally need to file a new NADA, rather than a supplemental application.

The guidance can be found in the Nov. 7, 2002, Federal Register and is posted at www.fda.gov/cvm/guidance/published.htm#documents. Single copies can be obtained by sending a self-addressed adhesive label to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855.

Comments regarding this final guidance should be sent to the Dockets Management Branch (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments can be submitted at www.fda.gov/dockets/ecomments. All comments should be identified with Docket Number 99N-2912.

Additional information is contained in the Nov. 8, 2002, Federal Register (www.fda.gov/OHRMS/DOCKETS/98fr/02-28472.htm) and from Dr. Marilyn N. Martinez, FDA/Center for Veterinary Medicine (HFV-130), 7500 Standish Place, Rockville, MD 20855; (301) 827-7577; or Mmartin1@cvm.fda.gov.