Drugs
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Breakdown of FDAAA Completed Pediatric Studies
Breakdown of studies completed between September 27, 2007 and June 30, 2012
| Type of Study | BPCA | BPCA + PREA | PREA | Total |
|---|---|---|---|---|
| Efficacy/Safety | 42 | 31 | 199 | 272 |
| PK/Safety | 9 | 36 | 19 | 64 |
| PK/PD | 14 | 8 | 8 | 30 |
| Safety | 5 | 4 | 24 | 33 |
| Other | 0 | 3 | 3 | 6 |
| Total | 70 | 82 | 253 | 405 |
Total number of studies completed under BPCA and PREA pursuant to FDAAA: 405
Total number of patients in completed FDAAA studies: 174,273
22,885 in BPCA studies
36,657 in CDER PREA studies
114,731 in CBER PREA studies (Vaccines and Blood Products)
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