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FDA: What's New, DrugsOct 15, 2026

Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products - 09/10/2026

FDA’s CDER SBIA announced a virtual workshop on September 10, 2026, for researchers and developers of topical and transdermal generic drugs. FDA experts will discuss bioequivalence recommendations, modeling alternatives and when in vivo studies may be needed.

Why it matters: FDA’s agenda connects bioequivalence methods with study needs, including when sensitization studies may be needed.

Regulations and guidanceTrial conduct and operationsAI summary
Read at FDA

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