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U.S. Department of Health and Human Services

About FDA

Number of contacts with foreign regulators to discuss scientific, ethical or safety issues related to pediatrics in the month

Dictionary: Pediatric studies are usually global given the limited number of sick children, particularly those afflicted with chronic disease. Given the global nature of pediatric trials, it is critical that FDA expand its global outreach to include other regulatory entities that oversee pediatric trials. International scientific communication and collaboration will enhance the safety, ethics and scientific rigor of pediatric studies, thus preventing children from becoming a commodity on the global market for economic gain.

A "contact" refers to written or oral communication between FDA and foreign regulators on matters involving pediatric issues. E-mail is an example of written communication and a teleconference, as oral communication.

Information is current as of March 31, 2014.

Fiscal Year - 2014

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TimeTargetNumber of Contacts
Oct 2013N/A20
Nov 2013N/A26
Dec 2013N/A16
Jan 2014N/A26
Feb 2014N/A44
Mar 2014N/A33
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 165

Number of oral communications with foreign regulators on drug products in the month (1)

Fiscal Year - 2014
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TimeTargetValue
Oct 2013N/A4
Nov 2013N/A3
Dec 2013N/A0
Jan 2014N/A4
Feb 2014N/A4
Mar 2014N/A3
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 18

Footnotes

  • (1) Tracking against this measure did not begin until November 2011.

Number of written exchanges with foreign regulators on drug products in the month (1)

Fiscal Year - 2014
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TimeTargetValue
Oct 2013N/A16
Nov 2013N/A23
Dec 2013N/A16
Jan 2014N/A22
Feb 2014N/A40
Mar 2014N/A30
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 147

Footnotes

  • (1) Tracking against this measure did not begin until November 2011.

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.