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

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM292507.pdf

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

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM292509.pdf

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

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM292510.pdf

Source: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm229642.htm