Product-Specific Guidance on Estradiol; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Estradiol" and a revised draft guidance for industry entitled "Draft Guidance on Estradiol." The new draft guidance and the revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for estradiol vaginal inserts and estradiol vaginal tablets.