Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661

摘要

The Food and Drug Administration (FDA, Agency, or we) is extending the effective date of the notice published in the Federal Register on May 27, 2026, titled Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661 (91 FR. 31462) (the "May 2026 Notice"), by 90 days. The effective date of the May 2026 Notice