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Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 1 with Keynote Address

Don D. Ashley, JD, Director of the Office of Compliance (OC), welcomes attendees to the “eDRLS Using CDER Direct” conference and Paul Loebach, Branch Chief for the Drug Registration and Listing Branch (DRLB), delivers his Keynote address.

Additional presenters, from OC’s DRLB (unless otherwise noted), and presentations include:

FDA Website: Resources Available to You
Don Duggan

Drug Establishment Registration 101- The Basics
Office of Compliance:
Regie Samuel
Vikas Arora, PharmD; Office of Program and Regulatory Operations
Puii Huber
For slides and additional information:
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Upcoming Training –
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Phone – (301) 796-6707 I (866) 405-5367

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