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U.S. Department of Health and Human Services

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PDUFA FY 2004 Percent of Filed NDAs and BLAs Approved on First Review Cycle

The percentage of priority applications approved on the first cycle was 46% and 45% for standard applications in FY 1997. The percentage of priority applications approved on the first cycle increased to 50% and dropped to 29% for standard applications in FY 1998. The percentage of priority applications approved on the first cycle increased again to 58% and increased to 39% for standard applications in FY 1999. The percentage of priority applications approved on the first cycle dropped to 45% and 31% for standard applications in FY 2000. The percentage of priority applications approved on the first cycle significantly dropped to 15% and 19% for standard applications in FY 2001. The percentage of priority applications approved on the first cycle significantly increased to 47% and 36% for standard applications in FY 2002. The percentage of priority applications approved on the first cycle increased again to 57% and dropped slightly to 35% for standard applications in FY 2003.

 

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