Zdrowie i gospodarka · 31/05/2007

FDA Releases Draft Guidance for Industry on Bioequivalence Recommendations for Specific Products

The Food and Drug Administration (FDA) has released a draft guidance for industry on bioequivalence recommendations for specific products, providing a new process for designing product-specific bioequivalence studies to support abbreviated new drug applications (ANDAs). The guidance is available on the FDA website, allowing applicants to access study guidance and comment on product-specific recommendations.