Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Estradiol" and a revised draft guidance for industry entitled "Draft Guidance on Estradiol." The new draft guidance and the revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2007-D-0369] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a new draft guidance for industry entitled “Draft Guidance on Estradiol” and a revised draft guidance for industry entitled “Draft Guidance on Estradiol.” The new draft guidance and the revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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. DATES: Submit either electronic or written comments on the draft guidance by February 6, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information…
Other Federal Register documents from the same docket.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Citation: 90 FR 56772
