Federal Register #FDA2007D0369

FDA Announces Revised Draft Product-Specific Guidances for Industry

This opportunity involves a government procurement by the Food and Drug Administration (FDA), under the Department of Health and Human Services. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are mentioned, as this is not a procurement for products or services. - No products or services are being requested; the notice is for the availability of revised draft product-specific guidances. - The guidances provide recommendations for the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). - Drug products covered by the guidances include: - Entrectinib - Ledipasvir; Sofosbuvir - Ferric Maltol - Ethinyl Estradiol; Levonorgestrel - Testosterone Undecanoate - Degarelix Acetate - Pretomanid - Diazepam - Vancomycin Hydrochloride - Azelaic Acid - Calcitonin salmon - Dasiglucagon hydrochloride - Glucagon - Liraglutide - Pegcetacoplan - Semaglutide - Teriparatide - Tirzepatide - Vosoritide - The notice invites public comment on the draft guidances, not bids for procurement. - No unique or notable procurement requirements are present, as this is a regulatory guidance announcement.

Description

The Food and Drug Administration (FDA) announces the availability of additional revised draft product-specific guidances. These guidances provide product-specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). The draft guidances were developed using a process previously described by the FDA and are open for public comment until September 28, 2026. The notice also includes information on how to submit comments and access the draft guidances online.

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