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In the March 9, 2015, Federal Register, FDA
announced the availability of additional draft and revised draft
product-specific bioequivalence ("BE") recommendations on
the design of BE studies to support abbreviated new drug
applications ("ANDAs"). FDA produced the recommendations
in accordance with the process outline in a 2010 guidance document. The new BE
recommendations for specific products are available on FDA's website.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
