FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DRUGS FOR HUMAN USE; DRUG EFFICACY STUDY IMPLEMENTATION: ESTROGEN-ANDROGEN FIXED-COMBINATION DRUG PRODUCTS; SECOND EXTENSION OF EFFECTIVE DATE OF FINAL RESOLUTION OF DRUG EFFICACY STUDY IMPLEMENTATION 7661

WASHINGTON, Aug. 27 -- Food and Drug Administration has issued a notice called: Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661.

The notice was published in the Federal Register on Aug. 27 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice published in the Federal Registeron May 27, 2026, entitled "Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets...