The US Food and Drug Administration (FDA) recently released several new draft guidances concerning topical generic drug products submitted under abbreviated new drug applications (ANDAs).
FDA’s recent draft guidances for industry on topical generic drugs include a guidance containing recommendations on in vivo bioequivalence studies for topical corticosteroids, a guidance for physicochemical and structural characterizations of topical drug products in ANDAs, a guidance with in vitro release test (IVRT) study recommendations for topical drug products in ANDA and a guidance on in vitro permeation test (IVPT) study recommendations for topical generic drugs…
