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Product safetyFDAUnited StatesImports

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

30 October 2026

In plain English

FDA is further extending the effective date of its final resolution of Drug Efficacy Study Implementation 7661 for estrogen-androgen fixed-combination drug products.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
30 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or Agency) 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"), as previously extended by the notice published in the Federal Reg
The full text is at the source

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