Zdrowie i gospodarka · 16/02/2016

Bioequivalence Recommendations for Cyclosporine; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on cyclosporine ophthalmic emulsion entitled "Draft Guidance on Cyclosporine." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cyclosporine ophthalmic emulsion. This draft guidance is a revised version of a previously issued draft guidance on the same subject.