FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: PRODUCT-SPECIFIC GUIDANCE ON ESTRADIOL; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Dec. 8 -- Food and Drug Administration has issued a notice called: Product-Specific Guidance on Estradiol; Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on Dec. 8 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Estradiol" and a revised draft guidance for industry entitled "Draft Guidance on Estradiol." The new draft guidance and the revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) st...