Opportunity
Federal Register #2026-22175
FDA Extends Effective Date for Estrogen-Androgen Combination Drug Resolution
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 30, 2026
Identifier
2026-22175
The U.S. Food and Drug Administration issued a regulatory notice concerning estrogen-androgen combination drug products, not a procurement opportunity. - Government agency: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). - Notice: The FDA extended the effective date of its final resolution of Drug Efficacy Study Implementation 7661 to allow more time to consider issues raised by interested parties. - Products mentioned: Syntest D.S. and Syntest H.S. tablets; no quantities or part numbers are provided. - OEMs and vendors: None identified by name. - Procurement: No products or services are being requested, and no contract value is stated.
Description
The FDA notice extends the effective date of its May 27, 2026 notice concerning estrogen-androgen fixed-combination drug products, including Syntest D.S. and Syntest H.S. tablets. The underlying notice addressed the withdrawal of hearing requests and the final resolution of Drug Efficacy Study Implementation 7661. The effective date, previously extended to November 4, 2026, is further extended by six months to May 4, 2027, to allow the FDA additional time to consider issues raised by interested parties.