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Is US FDA Preparing to Remove Some Fed Study Requirements For Generic Bioequivalence?

 
• By Derrick Gingery

New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.

fasting
New ICH draft guidance states only fasting studies should be required for most immediate-release solid oral dosage form generics to show bioequivalence. • Source: Shutterstock

Opinions inside the US Food and Drug Administration on requiring fed studies in generic drug development may be softening.

New International Council for Harmonisation (ICH) guidance could eventually push the agency to mandate only fasting studies for most immediate-release solid oral dosage products. Lei Zhang, deputy director of the...

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