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U.S. Department of Health and Human Services

About FDA

Number of pediatric studies completed (under both PREA and BPCA)

Dictionary: Pediatric studies are clinical trials generally conducted in patients ages 0-16 years of age. The Best Pharmaceuticals for Children Act (BPCA) provides financial incentives to pharmaceutical companies for conducting studies in pediatric patients according to a Written Request from the Agency describing specific pediatric studies that may produce health benefits in the pediatric population for an active moiety. The Pediatric Research Equity Act (PREA) requires that pharmaceutical companies conduct studies in pediatric patients when the proposed or approved use(s) in adults represent(s) a meaningful therapeutic benefit over existing therapies, is likely to be used in a substantial number of pediatric patients, and is anticipated to be safe and effective in the pediatric population.

Information is current as of September 30, 2014.

Fiscal Year - 2014

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TimeTargetNumber
Oct 2013N/A14
Nov 2013N/A0
Dec 2013N/A3
Jan 2014N/A1
Feb 2014N/A0
Mar 2014N/A3
Apr 2014N/A7
May 2014N/A4
Jun 2014N/A4
Jul 2014N/A5
Aug 2014N/A3
Sep 2014N/A3

FY 2014 Total: 47

Footnotes

  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.

Number of pediatric studies deferred (under PREA)

Fiscal Year - 2014

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TimeTargetNumber
Oct 2013N/A7
Nov 2013N/A15
Dec 2013N/A3
Jan 2014N/A5
Feb 2014N/A3
Mar 2014N/A9
Apr 2014N/A7
May 2014N/A9
Jun 2014N/A9
Jul 2014N/A2
Aug 2014N/A19
Sep 2014N/A11

FY 2014 Total: 99

Number of written requests issued

Fiscal Year - 2014

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TimeTargetNumber
Oct 2013N/A3
Nov 2013N/A0
Dec 2013N/A0
Jan 2014N/A1
Feb 2014N/A0
Mar 2014N/A4
Apr 2014N/A1
May 2014N/A1
Jun 2014N/A1
Jul 2014N/A2
Aug 2014N/A1
Sep 2014N/A3

FY 2014 Total: 17

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.