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Zdrowie i gospodarka · 10.02.2009

Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Extension of Comment Period

The Food and Drug Administration (FDA) is extending to March 19, 2009, the comment period for the draft guidance for industry entitled "Bioequivalence Recommendation for Vancomycin HCl" that published in the Federal Register of December 16, 2008 (73 FR 76362). The draft guidance provides specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for vancomycin HCl capsules. FDA is taking this action in response to requests for an extension of the comment period to allow interested persons additional time to submit comments.

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