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  5. On-demand Webinar: eCTD Submissions of Promotional Labeling and Advertising Materials – Aug. 12, 2019
  1. CDER Small Business & Industry Assistance (SBIA)

On-demand Webinar: eCTD Submissions of Promotional Labeling and Advertising Materials – Aug. 12, 2019

 

Topic & Presentation

Speakers

eCTD Submissions of Promotional Labeling and Advertising Materials

  

What’s New in the OPDP Electronic Submissions Final Guidance?

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

 

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Slides

This on-demand webinar is FREE. It was recorded on August 12, 2019.

On June 24, 2019, FDA published a final guidance titled “Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs.” The presentation will provide an overview of the updates and revisions between the draft and final versions of the guidance.

Topics Covered

  • Transition period of 24-months for promotional submissions in eCTD format
  • Overview of changes from the draft to final guidance
  • Resources available for companies transitioning to eCTD

FDA SPEAKER

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

INTENDED AUDIENCE

  • Regulatory affairs professionals working submission of promotional materials to OPDP
  • eCTD publishers and vendors

LEARNING OBJECTIVES

  • Identify the promotional submissions that will be required in eCTD at the end of the 24-month transition period.
  • List the changes between the draft and final versions of the OPDP electronic submissions guidance.
  • Identify the FDA resources available to support companies transitioning promotional submissions to eCTD format.

FDA RESOURCES

Contact

For questions concerning the webinar, please contact CDER SBIA at: CDERSBIA@fda.hhs.gov or call (866) 405-5367 | (301) 796-6707
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