Drugs

Breakdown of FDAAA Completed Pediatric Studies

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

Type of Study BPCA BPCA + PREA PREA Total
 Efficacy/Safety 45 31 201 277
 PK/Safety 9 40 20 69
 PK/PD 14 8 9 31
 Safety 6 4 25 35
 Other 2 10 45 57
 Total 76 93 300 469
  • 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: 05/10/2017
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