Drugs
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Breakdown of FDAAA Completed Pediatric Studies
Breakdown of studies completed between September 27, 2007 and December 5, 2012
| Type of Study | BPCA | BPCA + PREA | PREA | Total |
|---|---|---|---|---|
| Efficacy/Safety | 43 | 31 | 199 | 273 |
| PK/Safety | 9 | 36 | 21 | 66 |
| PK/PD | 14 | 8 | 9 | 31 |
| Safety | 6 | 4 | 25 | 35 |
| Other | 3 | 3 | 16 | 22 |
| Total | 75 | 82 | 270 | 425 |
Total number of studies completed under BPCA and PREA pursuant to FDAAA: 425
Total number of patients in completed FDAAA studies: 175,209
23,339 in BPCA studies
32,650 in CDER PREA studies
119,220 in CBER PREA studies (Vaccines and Blood Products)
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