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DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Fax# 7607682589 October 28, 2003 11:OO am to 01:OO pm Location: MST Arizona Western College 2020 South Avenue
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lst 3 - fda refers to the Form FDA 3674 which is used to report bioavailability and bioequivalence data for generic drug products.
Manufacturers of generic drug products are required to file lst 3 - fda.
lst 3 - fda can be filled out electronically through the FDA's Electronic Submissions Gateway (ESG) or manually by submitting a paper copy to the FDA.
The purpose of lst 3 - fda is to provide bioavailability and bioequivalence data for generic drug products to the FDA.
Information such as study designs, results, and conclusions regarding bioavailability and bioequivalence studies must be reported on lst 3 - fda.
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