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The purpose of this public meeting was to provide stakeholders the opportunity to address specific topics and present their views as FDA prepares the PDUFA IT Plan that will be released for public comment by December 31, 2007. The meeting format included presentations by FDA and various stakeholders. The meeting agenda, transcript, and presentations are available on the FDA Web site. Please see the Federal Register (FR) notice [Text] [PDF 56 KB] for additional information about meeting content.
Organizations and individuals may submit comments to the docket (2007N-0347) until November 3, 2007.
Docket No. 2007N-0347; Documents and comments received by the Division of Dockets Management may be posted on the Internet. Please do not include personal identifying information, i.e. date of birth, social security number, medical information, etc., in your correspondence.
Documents are on display for public inspection at the Division of Dockets Management, 5630 Fishers Lane (Room 1061), HFA-305, Rockville, MD, 20852; 301-827-6860; TTY/TDD Users 1-800-735-2258.