Zdrowie i gospodarka · 27/02/2026

FDA Announces Availability of Additional Draft and Revised Draft Product-Specific Guidances

The FDA is announcing the availability of additional draft and revised draft product-specific guidances, which provide recommendations on bioequivalence studies to support ANDAs. These guidances were developed using the process described in the 2010 guidance for industry entitled "Bioequivalence Recommendations for Specific Products".