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U.S. Department of Health and Human Services

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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 December 31, 2014.

Fiscal Year - 2015

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TimeTargetNumber of Contacts
Oct 2014N/A39
Nov 2014N/A33
Dec 2014N/A32
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: 104

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

Fiscal Year - 2015
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TimeTargetValue
Oct 2014N/A3
Nov 2014N/A3
Dec 2014N/A5
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: 11

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 - 2015
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TimeTargetValue
Oct 2014N/A36
Nov 2014N/A30
Dec 2014N/A27
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: 93

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.