WORLD TRADE
ORGANIZATIONG/SPS/N/USA/265/Add.1
13 November 2000
(00-4796)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
Addendum
The following communication by the United States is being circulated:
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The Food and Drug Administration (FDA) is announcing the availability of a final guidance
for industry entitled "The Use of Published Literature in Support of New Animal Drug Approval".
The final guidance is intended to fulfill the section of the FDA Modernization Act of 1997 (FDAMA)
that requires the agency to issue guidance to clarify the circumstances in which published matter may
be the basis for approval of a supplemental application.  The final guidance also clarifies the
circumstances in which published literature may be the basis for approval of an original application.The final guidance is intended to provide spec ific 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
approvals.
The Federal Register notice and the Final Guidance document are available from the US SPS
Enquiry Point/Notification Authority.
Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov
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