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U.S. Department of Health and Human Services

Animal & Veterinary

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Guidance Available On Developing Supplemental NADAS

November 8, 2002

FDA's Center for Veterinary Medicine (CVM) announced the availability of final guidance for industry (GFI) entitled "Development of Supplemental Applications for Approved New Animal Drugs"(GL #82) in the November 7, 2002, Federal Register. Final guidance #82 is intended to provide specific guidance for sponsors of new animal drug applications (NADAs) on the development of supplemental applications for approved new animal drugs. This guidance explains how and when drug sponsors may use data collected for original NADAs to support the technical sections of a supplemental NADA. The guidance also explains when 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.

Final guidance #82 is posted on the FDA/Center for Veterinary Medicine Home Page. Single copies of the guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855. Please send a self-addressed adhesive label to assist in processing your request.

Comments and suggestions regarding this final guidance should be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA. All comments should be identified with Docket Number 99N-2912. General comments on Agency guidance documents are welcome at any time.

This final guidance represents the Agency's current thinking on the information to support the approval of supplements. It does not create or confer any rights for or on any person and does not operate to bind the FDA or public. An alternative approach may be used if such approach satisfies the requirements of applicable statutes and regulations.

Additional information on this guidance document is contained in the November 8, 2002 Federal Register and from Dr. Marilyn N. Martinez, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-7577.

 

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855