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Breakdown of FDAAA Completed Pediatric Studies


Breakdown of studies completed between September 27, 2007 and November 18, 2013



  • Total number of studies completed under BPCA and PREA pursuant to FDAAA: 469

  • Total number of patients in completed FDAAA studies: 178,425

    • 23,628 in BPCA studies

    • 32,839 in CDER PREA studies

    • 121,958 in CBER PREA studies (Vaccines and Blood Products)


Page Last Updated: 10/05/2016
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