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New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific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New ICH draft guidance states only fasting studies should be required for most immediate-release solid oral dosage form generics to show bioequivalence.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

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