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  1. Development Resources

Breakdown of FDAAA Completed Pediatric Studies

Breakdown of studies completed between September 27, 2007 and December 31, 2019

Type of Study BPCA BPCA + PREA PREA Rule Total
 Efficacy/Safety 87 138 414 0 639
 PK/Safety 36 82 43 0 161
 PK/PD 25 19 27 0 71
 Safety 9 20 47 0 76
 Other 10 23 124 1 158
 Total 167 282 655 1 1105
  • Total number of studies completed under BPCA and PREA pursuant to FDAAA: 1105

  • Total number of patients in completed FDAAA studies: 323,964

    • 31,088 in BPCA studies

    • 63,419 in CDER PREA studies

    • 228,741 in CBER PREA studies (Vaccines and Blood Products)