federal_register: 2025-22249

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2025-22249 Product-Specific Guidance on Estradiol; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Estradiol" and a revised draft guidance for industry entitled "Draft Guidance on Estradiol." The new draft guidance and the revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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. 2025-12-08 2025 12 https://www.federalregister.gov/documents/2025/12/08/2025-22249/product-specific-guidance-on-estradiol-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2025-12-08/pdf/2025-22249.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Estradiol" and a revised draft guidance for industry entitled "Draft Guidance on Estradiol."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...

Links from other tables