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U.S. Department of Health and Human Services

Animal & Veterinary

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Draft Guidance On Administrative NADA Process Available For Comment

November 7, 2002

FDA's Center for Veterinary Medicine (CVM) announced the availability of draft guidance for industry (GFI) entitled "The Administrative New Animal Drug Application Process"(GL #132) in the November 6, 2002, Federal Register.

Draft guidance #132 describes CVM's Administrative New Animal Drug Application (Administrative NADA) process. An Administrative NADA is a new animal drug application that is submitted after all of the technical sections that fulfill the requirements for the approval of the new animal drug have been reviewed by CVM, and the Center has issued a technical section complete letter for each of those technical sections.

CVM encourages drug sponsors to submit data for review at the most appropriate and productive times in the drug development process rather than submitting all data at one time. Sponsors may submit data in support of discrete technical sections for CVM “phased review” during the investigation of the new animal drug. Phased review and direct review create greater efficiencies that facilitate the approval of new animal drugs. This draft guidance defines what an Administrative NADA is, describes the phased review process, and discusses how sponsors should submit an Administrative NADA and the time frame for review.

This draft guidance represents the CVM's current thinking on this matter. It does not create or confer any rights for or on any person and does not bind CVM or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

Draft guidance #132 is posted on the FDA/Center for Veterinary Medicine Home Page. Single copies of the draft guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855.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Comments and suggestions regarding this draft guidance should be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.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 02D-0449, and written or electronic comments on the draft guidance should be submitted by January 21, 2003 to ensure their adequate consideration in preparation of the final document. General comments on Agency guidance documents are welcome at any time.

For questions regarding this draft guidance document, contact Gail Schmerfeld, Center for Veterinary Medicine (HFV- 100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-1796.


Contact FDA

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

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855