CDER SBIA On-demand Webinar | eCTD Submissions of Promotional Labeling and Advertising Materials

CDER Small Business and Industry Assistance (SBIA) On-demand Webinar: eCTD Submissions of Promotional Labeling and Advertising Materials

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This on-demand webinar is FREE. 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 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.