FDA Announces New And Revised Product-Specific Bioequivalence Recommendations

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In the June 17, 2016, Federal Register, FDA announced the availability of 19 new and 19 revised draft product-specific bioequivalence recommendations.

United States Food, Drugs, Healthcare, Life Sciences

Cristiana Spontoni,Colleen Heisey,Laura Koman

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In the June 17, 2016, Federal Register, FDA announced the availability of 19 new and 19 revised draft product-specific bioequivalence recommendations. The draft recommendations provide product-specific guidance on the design of bioequivalence studies to support abbreviated new drug applications. These 38 draft recommendations and FDA's other product-specific bioequivalence recommendations (1,454 total) are available on FDA's website. Comments are due August 16, 2016.

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