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.
- 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
Lead Project Manager
Office of Prescription Drug Promotion (OPDP) | CDER | FDA
- Regulatory affairs professionals working submission of promotional materials to OPDP
- eCTD publishers and vendors
- 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 GUIDANCE DOCUMENT - Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs
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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