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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, 2012.

• FY 2010
• FY 2011
• FY 2012
• FY 2013
• All

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

Fiscal Year - 2013

Time	Target	Value
Oct 2012	N/A	5
Nov 2012	N/A	3
Dec 2012	N/A	2
Jan 2013	N/A	TBD
Feb 2013	N/A	TBD
Mar 2013	N/A	TBD
Apr 2013	N/A	TBD
May 2013	N/A	TBD
Jun 2013	N/A	TBD
Jul 2013	N/A	TBD
Aug 2013	N/A	TBD
Sep 2013	N/A	TBD

FY 2013 YTD: 10

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

Time	Target	Value
Oct 2012	N/A	29
Nov 2012	N/A	21
Dec 2012	N/A	21
Jan 2013	N/A	TBD
Feb 2013	N/A	TBD
Mar 2013	N/A	TBD
Apr 2013	N/A	TBD
May 2013	N/A	TBD
Jun 2013	N/A	TBD
Jul 2013	N/A	TBD
Aug 2013	N/A	TBD
Sep 2013	N/A	TBD

FY 2013 YTD: 71

Footnotes

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