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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 September 30, 2013.

Fiscal Year - 2012

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TimeTargetNumber of Contacts
Oct 2011N/A12
Nov 2011N/A19
Dec 2011N/A28
Jan 2012N/A32
Feb 2012N/A42
Mar 2012N/A33
Apr 2012N/A40
May 2012N/A31
Jun 2012N/A27
Jul 2012N/A13
Aug 2012N/A24
Sep 2012N/A26

FY 2012 Total: 327

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

Fiscal Year - 2012
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TimeTargetValue
Nov 2011N/A4
Dec 2011N/A5
Jan 2012N/A6
Feb 2012N/A5
Mar 2012N/A3
Apr 2012N/A4
May 2012N/A5
Jun 2012N/A6
Jul 2012N/A4
Aug 2012N/A6
Sep 2012N/A7

FY 2012 Total: 55

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 - 2012
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TimeTargetValue
Nov 2011N/A15
Dec 2011N/A23
Jan 2012N/A26
Feb 2012N/A37
Mar 2012N/A30
Apr 2012N/A36
May 2012N/A26
Jun 2012N/A21
Jul 2012N/A9
Aug 2012N/A18
Sep 2012N/A19

FY 2012 Total: 260

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.