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 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 - 2012

Time	Target	Value
Nov 2011	N/A	4
Dec 2011	N/A	5
Jan 2012	N/A	6
Feb 2012	N/A	5
Mar 2012	N/A	3
Apr 2012	N/A	4
May 2012	N/A	5
Jun 2012	N/A	6
Jul 2012	N/A	4
Aug 2012	N/A	6
Sep 2012	N/A	7

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

Time	Target	Value
Nov 2011	N/A	15
Dec 2011	N/A	23
Jan 2012	N/A	26
Feb 2012	N/A	37
Mar 2012	N/A	30
Apr 2012	N/A	36
May 2012	N/A	26
Jun 2012	N/A	21
Jul 2012	N/A	9
Aug 2012	N/A	18
Sep 2012	N/A	19

FY 2012 YTD: 260

Footnotes

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