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What Is a PDUFA Date?

By Keith Speights – Updated Jul 3, 2025 at 12:59AM

Key Points

  • FDA has a set timeline to review drugs; a norm is 10 months, called a PDUFA date.
  • Priority Review can shorten this to six months for critical treatments.
  • PDUFA dates are impactful, influencing when drugs might enter the market.
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