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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, 2014.

Fiscal Year - 2015

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TimeTargetNumber
Oct 2014N/A6
Nov 2014N/A5
Dec 2014N/A8
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 19

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 - 2015

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TimeTargetNumber
Oct 2014N/A8
Nov 2014N/A3
Dec 2014N/A13
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 24

Number of written requests issued

Fiscal Year - 2015

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TimeTargetNumber
Oct 2014N/A2
Nov 2014N/A1
Dec 2014N/A0
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 3

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.