Zdrowie i gospodarka · 24/08/2026

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

The US Food and Drug Administration (FDA) has made additional draft and revised draft product-specific guidances available, providing recommendations on bioequivalence studies for abbreviated new drug applications (ANDAs). These guidances were developed using the process outlined in the FDA's June 11, 2010, guidance titled 'Bioequivalence Recommendations for Specific Products'.