Electronic Drug Registration and Listing
Using CDER Direct
October 8, 2020
Join registration and listing staff in this workshop dedicated to assisting industry with creating complete and accurate registration and listing submissions. Ask questions to FDA subject matter experts.
The agenda is subject to change. Updated versions will be linked here as they become available. The current version is 5, uploaded on October 5, 2019.
This PDF file contains brief biographies of the FDA speakers participating in the conference.
ZIP of the Workshop Slides
- Keynote: eDRLS and the COVID-19 National Health Emergency
- Session 1: Labeler Code Request
- Session 2: Establishment Registration
- Session 3: Drug Listing
- Session 4: 503B Compounder Product Reporting using CDER Direct
- Session 5: Establishment Registration and Drug Listing Compliance Program
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