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FDA Releases Product-Specific BE Recommendations

06/20/2013

Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE)recommendations. The recommendations provide product-specific guidance on the design of BE studies to support ANDAs. New draft product-specific recommendations include drug products containing the following active ingredients: apixaban, artemether; balsalazide disodium, cycloserine, eltrombopag olamine, and sodium ferric gluconate. To view this notice, click here.

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