Draft Guidance for Industry on Topical Dermatological Drug Product NDA's and ANDA'sIn Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Topical Dermatological Drug Product NDA's and ANDA's--In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies.'' The draft guidance is intended to provide recommendations to sponsors of new drug applications (NDA's), abbreviated new drug applications (ANDA's), and supplements who intend to perform bioavailability and bioequivalence studies for topically applied dermatological drug products during either the preapproval or postapproval period. The agency is seeking comments on the draft guidance.