2025-22249: Product-Specific Guidance on Estradiol; Draft Guidance for Industry; Availability
Public comment closed .
Get alerted when the next rule lands
New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.
Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.
Create a free account & build one →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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Estradiol" and a revised draft guidance for industry entitled "Draft Guidance on Estradiol." The new draft guidance and the revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for estradiol vaginal inserts and estradiol vaginal tablets.
The agency’s own summary, as published.
Don't miss the comment window
One Click Politics alerts you on every deadline, hearing, and rule change.
See all rules with comments due soon →