Promotional Submissions in eCTD Format – Grouped Submissions August 31, 2021

Virtual | Virtual

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• Date: August 31, 2021

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Visit the CDER Small Business and Industry Assistance Webpage

Download Slides

FDA will discuss:

• the purpose and benefits of grouped submissions in eCTD format to the Office of Prescription Drug Promotion (OPDP),
• the content and structure of grouped submissions to OPDP in eCTD format,
• common errors associated with grouped submissions and how to avoid them.

AUDIENCE

• Regulatory affairs professionals
• Submitters
• Publishers who submit promotional materials to CDER’s Office of Prescription Drug Promotion (OPDP) in eCTD format

TOPICS

• Promotional Submissions in eCTD format
• Grouped Promotional Submissions
• Submissions to OPDP in eCTD format

FDA SPEAKERS

Jason Cober
Lead Project Manager
Office of Prescription Drug Promotion (OPDP) | CDER | FDA

FDA RESOURCES

• OPDP Electronic Submissions Guidance 
• OPDP eCTD Webpage 
• OPDP eCTD Mailbox
• eCTD Sample Submissions