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Guidance on BE Recommendations for Iron Sucrose

11/06/2013

Federal Register Notice: FDA is making available a draft guidance for industry entitled Bioequivalence Recommendations for Iron Sucrose. The recommendations provide specific guidance on the design of bioequivalence studies to support ANDAs for iron sucrose injection. The guidance is a revised version of a previously issued draft guidance on the same subject. To download this guidance, click here. To view this notice, click here.

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