Zdrowie i gospodarka · 26/08/2013

FDA Releases Revised Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection

The Food and Drug Administration (FDA) has made available a revised draft guidance for industry, titled 'Draft Guidance on Risperidone,' which outlines specific recommendations for designing bioequivalence studies to support abbreviated new drug applications (ANDAs) for risperidone injection.