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Zdrowie i gospodarka · 06/11/2013

FDA Releases Draft Guidance on Bioequivalence Recommendations for Iron Sucrose

The Food and Drug Administration (FDA) has released a draft guidance for industry on bioequivalence recommendations for iron sucrose, providing specific guidance on designing bioequivalence studies to support abbreviated new drug applications (ANDAs) for iron sucrose injection.

Source: Federal Register — Food and Drug AdministrationOpen original release →