Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—NOTICES: FDA extends review of estrogen-androgen drug decision, (Aug 31, 2026)

By WK Editorial Staff

The second delay gives FDA additional time to evaluate concerns raised by stakeholders before restrictions on the interstate distribution of certain unapproved estrogen-androgen combination drugs take effect.

FDA has again delayed the effective date of its final resolution of Drug Efficacy Study Implementation (DESI) 7661, which concerns estrogen-androgen fixed-combination drug products. In its May 2026 notice, the agency concluded that all outstanding hearing requests had been withdrawn and determined that the products lack substantial evidence of effectiveness for treating moderate to severe menopausal vasomotor symptoms in patients who do not respond adequately to estrogen alone. FDA also stated that interstate shipment of unapproved versions of the products would become unlawful. After interested parties raised concerns following publication of the notice, FDA first postponed the effective date to September 24, 2026, and has now extended it again to November 4, 2026, to allow additional time to consider those issues (Notice, 91 Fed. Reg. 55348 (Aug. 27, 2026)).

Dates. The effective date of the May 27, 2026, notice (91 FR 31462), as previously extended, is further extended to November 4, 2026.

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