FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: PRODUCT-SPECIFIC GUIDANCE ON ROFLUMILAST; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, May 21 -- Food and Drug Administration has issued a notice called: Product-Specific Guidance on Roflumilast; Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on May 21 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Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Roflumilast." The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for roflumilast topical cream.

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