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In this section: Development Resources

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

Total number of studies completed under BPCA and PREA pursuant to FDAAA: 1105
Total number of patients in completed FDAAA studies: 323,964
- 31,088 in BPCA studies
- 63,419 in CDER PREA studies
- 228,741 in CBER PREA studies (Vaccines and Blood Products)

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