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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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