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FDA Releases Product-Specific BE Guidance

01/28/2016

Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommendations for 31 products. The recommendations provide product-specific guidance on the design of BE studies to support ANDAs. The products include recommendations for alprostadil, betamethasone dipropionate, ciclesonide, and elvitegravir. To view this notice, click here.

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