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Zdrowie i gospodarka · 16/12/2008

Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendation for Vancomycin HCl." The recommendation provides specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for vancomycin HCl capsules.

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