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U.S. Department of Health and Human Services

About FDA

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.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A25
Nov 2009N/A10
Dec 2009N/A14
Jan 2010N/A18
Feb 2010N/A19
Mar 2010N/A32
Apr 2010N/A19
May 2010N/A27
Jun 2010N/A25
Jul 2010N/A22
Aug 2010N/A16
Sep 2010N/A15

Footnotes

  • (1) PDUFA reviews are captured by OND

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.