Drugs
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Breakdown of FDAAA Completed Pediatric Studies
Breakdown of studies completed between September 27, 2007 and April 5, 2013
| Type of Study | BPCA | BPCA + PREA | PREA | Total |
|---|---|---|---|---|
| Efficacy/Safety | 43 | 31 | 200 | 274 |
| PK/Safety | 9 | 37 | 20 | 66 |
| PK/PD | 14 | 8 | 9 | 31 |
| Safety | 6 | 4 | 25 | 35 |
| Other | 3 | 6 | 21 | 30 |
| Total | 75 | 86 | 275 | 436 |
Total number of studies completed under BPCA and PREA pursuant to FDAAA: 436
Total number of patients in completed FDAAA studies: 175,209
23,412 in BPCA studies
32,577 in CDER PREA studies
121,958 in CBER PREA studies (Vaccines and Blood Products)
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