Dec, 19 2025

Priority vs Standard Review: How FDA Prioritizes Generic Drug Applications

The FDA uses priority and standard review timelines to speed up or slow down generic drug approvals. Priority review cuts approval time to 8 months for first generics, shortage drugs, or improved formulations. A new pilot rewards U.S. manufacturing to strengthen supply chains.

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Dec, 12 2025

How FDA Approval Costs for Generic Drugs Impact Healthcare Prices

FDA approval costs for generic drugs are high and complex, causing delays that keep prices up. Learn how regulatory fees, vague feedback, and policy changes impact access and savings - and what’s being done to fix it.

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