FDA Issues Draft Guidance on Estradiol Products
December 09, 2025
December 09, 2025
WASHINGTON, Dec. 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has announced the availability of two draft guidances to assist industry in developing generic versions of estradiol vaginal products.
FDA published a revised draft guidance for industry entitled "Draft Guidance on Estradiol" for vaginal tablets and a separate draft guidance with the same title for vaginal inserts.
When the documents are finalized, they . . .
FDA published a revised draft guidance for industry entitled "Draft Guidance on Estradiol" for vaginal tablets and a separate draft guidance with the same title for vaginal inserts.
When the documents are finalized, they . . .