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Number of pediatric reviews, including reviews for pediatric plans, written requests, pediatric protocols, study reports, and labeling, per month (1)

Dictionary: These pediatric reviews are a composite number including, but not limited to the following: a) supplemental pediatric studies submitted, b) Pediatric Plans submitted for deferred studies under the Pediatric Research Equity Act (PREA), c) waived or partially waived studies under PREA, and d) Written Requests for pediatric studies issued under the Best Pharmaceuticals for Children Act (BPCA). The PREA and the BPCA were renewed as part of the FDA Amendments Act of 2007 to both protect children from harmful drug effects and to provide the best care possible for children. The performance of the duties related to these acts depends upon careful planning of pediatric studies, and vigilance regarding the interpretation and analysis of pediatric studies already conducted. This due diligence is important so as to not undermine the protection of children's health as provided by the Acts. Therefore the Office of Clinical Pharmacology considers the careful tracking of pediatric studies to be essential to adequately insure the proper treatment of children as intended under PREA and BPCA.

This measure has been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

• FY 2010
• FY 2011
• FY 2012
• All

Footnotes

• (1) PDUFA reviews are captured by OND