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U.S. Department of Health and Human Services

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PDUFA FY 2002 Median Approval Times

  • The median approval time for standard applications filed in FY93 was 22 months. Approval time dropped to 12 months for those filed in FY97, and has been volatile since then. Median approval time for standard applications filed in FY00, the most recent year for which times can be estimated, is 14.8 months.
  • The median approval time for priority applications filed in FY93 was a little over 12 months, dropped to 6 months by FY98, and remained there through FY00. Median approval times for priority applications filed in FY01 are estimated to be 9.8 months.

 

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