2026-12933: 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
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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 is hereby extended from June 26, 2026, to September 24, 2026. This extension is necessary to allow FDA sufficient time to consider issues raised by interested parties following publication of the May 2026 Notice.
The agency’s own summary, as published.
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