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U.S. Department of Health and Human Services

Drugs

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Breakdown of FDAAA Completed Pediatric Studies

   

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

Type of StudyBPCABPCA + PREAPREATotal
 Efficacy/Safety4531201277
 PK/Safety9402069
 PK/PD148931
 Safety642535
 Other2104557
 Total7693300469

 

  • 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)