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FDA Releases Additional Product-Specific BE Recs

11/06/2013

ral Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommendations on the design of BE studies to support ANDAs. The products include bedaquiline fumarate, bupropion hydrochloride, etodolac, nicotine, acitretin, and cefixime. To view this notice, click here.

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