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 | Total |
|---|---|---|---|---|
| Efficacy/Safety | 87 | 138 | 414 | 639 |
| PK/Safety | 36 | 82 | 43 | 161 |
| PK/PD | 25 | 19 | 27 | 71 |
| Safety | 9 | 20 | 47 | 76 |
| Other | 10 | 23 | 124 | 158 |
| Total | 167 | 282 | 655 | 1105 |
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Total number of studies completed under BPCA and PREA pursuant to FDAAA: 1105
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Total number of patients in completed FDAAA studies: 323,964
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31,088 in BPCA studies
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63,419 in CDER PREA studies
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228,741 in CBER PREA studies (Vaccines and Blood Products)
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