Zdrowie i gospodarka · 02/08/2013

Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Mesalamine." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for mesalamine rectal suppositories. The draft guidance is a revised version of a previously issued draft guidance on the same subject.