FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: TOPICAL DERMATOLOGIC CORTICOSTEROIDS: IN VIVO BIOEQUIVALENCE; GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, July 14 -- Food and Drug Administration has issued a notice called: Topical Dermatologic Corticosteroids: In Vivo Bioequivalence; Guidance for Industry; Availability.

The notice was published in the Federal Register on July 14 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Topical Dermatologic Corticosteroids: In Vivo Bioequivalence." This guidance provides recommendations to applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroids of all potency groups (referred to in this notice as topical corticosteroids)...