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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 - 2013

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TimeTargetNumber of Contacts
Oct 2012N/A34
Nov 2012N/A24
Dec 2012N/A23
Jan 2013N/A35
Feb 2013N/A26
Mar 2013N/A30
Apr 2013N/A21
May 2013N/A39
Jun 2013N/A25
Jul 2013N/A26
Aug 2013N/A25
Sep 2013N/A20

FY 2013 Total: 328

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

Fiscal Year - 2013
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TimeTargetValue
Oct 2012N/A5
Nov 2012N/A3
Dec 2012N/A2
Jan 2013N/A5
Feb 2013N/A2
Mar 2013N/A4
Apr 2013N/A4
May 2013N/A4
Jun 2013N/A3
Jul 2013N/A6
Aug 2013N/A1
Sep 2013N/A3

FY 2013 Total: 42

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 - 2013
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TimeTargetValue
Oct 2012N/A29
Nov 2012N/A21
Dec 2012N/A21
Jan 2013N/A30
Feb 2013N/A24
Mar 2013N/A26
Apr 2013N/A17
May 2013N/A35
Jun 2013N/A22
Jul 2013N/A20
Aug 2013N/A24
Sep 2013N/A17

FY 2013 Total: 286

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.