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Tag: standard review FDA

Priority vs Standard Review: How FDA Prioritizes Generic Drug Applications

Priority vs Standard Review: How FDA Prioritizes Generic Drug Applications

  • Maria Witham
  • 24 November 2025
  • 0

The FDA uses priority and standard review paths for generic drugs. Priority review speeds up approval for first generics, drugs in shortage, or those with medical advantages-cutting approval time from 10 to 8 months. New rules now reward U.S.-made drugs.

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