April 19, 2000
DRAFT GUIDANCE AVAILABLE ON USING PUBLISHED LITERATURE IN SUPPORT OF NADA
The Food and Drug Administration (FDA) announced in the April 19, 2000, Federal Register, the availability for comment of draft guidance for industry (GFI) entitled "The Use of Published Literature in Support of New Animal Drug Approval" (#106.) This draft GFI is intended to fulfill section 403(b)(1) of the FDA Modernization Act of 1997 (FDAMA), which requires the Agency to issue guidance to clarify the circumstances in which published matter may be the basis for approval of a supplemental new animal drug application (NADA.) It also clarifies the circumstances in which published literature may be the basis for approval of an original NADA. This draft GFI is intended to provide specific advice on when FDA may be able to rely on published literature, with or without the submission of underlying data, to support new animal drug approval.
Copies of this guidance document may be obtained on the Internet from the CVM Home Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755.
Written comments on the guidance document may be submitted by July 18, 2000, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The full title of the guidance document and Docket No. 00D-0790 should be included on the comments.
Additional information about this guidance document is included in the April 19, 2000, Federal Register. Questions about this guidance document may be directed to Gail Schmerfeld, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1620, E-mail: gschmer1@cvm.fda.gov.
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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