August 3, 2004
Draft Guidance on Bioequivalence Waivers Available for Comment
The Food and Drug Administration (FDA) is announcing the availability for comment of a draft guidance for industry entitled “Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles” (GFI #171.)
The Generic Animal Drug and Patent Term Registration Act of 1988 permitted generic drug manufacturers to copy those pioneer drug products that were no longer subject to patent or other marketing exclusivity protection. The approval for marketing these generic products is based, in part, upon a demonstration of bioequivalence between the generic product and pioneer product. This guidance clarifies circumstances under which FDA believes the demonstration of bioequivalence required by the statute does not need to be established on the basis of in vivo studies. The data submitted in support of the waiver request are necessary to validate the waiver decision.
Draft guidance #171 is posted on the FDA/Center for Veterinary Medicine Home Page. Single copies of the draft guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855, 301-827-3800. Please send one self-addressed adhesive label to assist in processing your request.
Written or electronic comments on the draft guidance should be submitted by October 18, 2004, to ensure their adequate consideration in preparation of the final document. General comments on agency guidance documents are welcome at any time. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 10-61, Rockville, MD 20852. Electronic comments on the draft guidance may be submitted to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA. Comments should be identified with the full title of the draft guidance and Docket Number 2004D-0283.
Further information about the draft guidance may be found in the August 3, 2004, Federal Register (http://www.fda.gov/OHRMS/DOCKETS/98fr/04-17627.htm ) and from Dr. Marilyn Martinez, Center for Veterinary Medicine (HFV- 130), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, e-mail: mmartin1@cvm.fda.gov.
This draft Level 1 guidance is being distributed for comment purposes only and is not intended for implementation at this time. This draft guidance is being issued consistent with FDA’s good guidance practices regulation. This draft guidance, when finalized, will represent the Agency’s current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate method may be used as long as it satisfies the requirements of applicable statutes and regulations.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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