How to Comply with FDA Requirements for Submission of Bioequivalence Data for ANDA (Abbreviated New Drug Application)
Abstract:Abbreviated New Drug Application (ANDA) is an application for approval of a generic drug. This application is submitted to the FDA Center for Drug Evaluation and Research (CDER) for review and approval. Using bioequivalence for generic drug approval was established by the Waxman-Hatch Act.
This article describes the requirements for bioequivalence data submission for ANDA to the FDA.
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