20 February 2012

FDA: Electronic Submission Presentation – (DIA Module 1 Townhall Webinar)

FDA has posted the recently presented presentation slides in the Electronics Submission Presentation webpage. These slides were presented in DIA Module 1 Townhall Webinar.

eCTD M1 Update: General Overview of the Comments, Constance Robinson, Regulatory Information Specialist, eSubmission Support, Office of Business Process Support, CDER

Draft Module 1 Update (1.15 Promotional Materials), Marci Kiester, Pharm D, Marci Kiester, Pharm.D., Associate Director of Operations, OPDP (formerly DDMAC), CDER

Key Modifications to Module 1, Jared Lantzy, Regulatory Information Specialist, Electronic Submission Support Team, Office of Business Informatics

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