Drugs
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Breakdown of FDAAA Completed Pediatric Studies
Breakdown of studies completed between September 27, 2007 and March 31, 2012
| Type of Study | BPCA | BPCA + PREA | PREA | Total |
|---|---|---|---|---|
| Efficacy/Safety | 42 | 29 | 167 | 238 |
| PK/Safety | 8 | 31 | 18 | 57 |
| PK/PD | 14 | 8 | 8 | 30 |
| Safety | 5 | 4 | 23 | 32 |
| Other | 0 | 3 | 9 | 12 |
| Total | 69 | 75 | 225 | 369 |
- Total number of studies completed under BPCA and PREA pursuant to FDAAA: 369
- Total number of patients in completed FDAAA studies: 167,382
- 22,485 in BPCA studies
- 30,166 in CDER PREA studies
- 114,731 in CBER PREA studies (Vaccines and Blood Products)
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