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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 December 31, 2013.

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A15
Nov 2012N/A4
Dec 2012N/A3
Jan 2013N/A4
Feb 2013N/A5
Mar 2013N/A7
Apr 2013N/A3
May 2013N/A4
Jun 2013N/A13
Jul 2013N/A1
Aug 2013N/A2
Sep 2013N/A0

FY 2013 Total: 61

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 - 2013

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TimeTargetNumber
Oct 2012N/A5
Nov 2012N/A2
Dec 2012N/A3
Jan 2013N/A6
Feb 2013N/A2
Mar 2013N/A4
Apr 2013N/A3
May 2013N/A0
Jun 2013N/A6
Jul 2013N/A9
Aug 2013N/A8
Sep 2013N/A3

FY 2013 Total: 51

Number of written requests issued

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A4
Dec 2012N/A3
Jan 2013N/A1
Feb 2013N/A2
Mar 2013N/A2
Apr 2013N/A1
May 2013N/A1
Jun 2013N/A0
Jul 2013N/A1
Aug 2013N/A1
Sep 2013N/A3

FY 2013 Total: 19

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.