Zdrowie i gospodarka · 22/02/2012

FDA Releases Draft and Revised Draft Bioequivalence Recommendations for Industry

The Food and Drug Administration (FDA) has released additional draft and revised draft product-specific bioequivalence (BE) recommendations, providing guidance on designing BE studies to support abbreviated new drug applications (ANDAs). These recommendations were developed based on the FDA's previous guidance for industry, announced in the Federal Register on June 11, 2010.