Paul Loebach, Branch Chief for the Drug Registration and Listing Branch (DRLB), delivers his closing remarks to the “eDRLS Using CDER Direct” Conference and engages with the audience in a question-and-answer panel.
Additional presenters, from the Office of Compliance’s Drug Registration and Listing Branch (OC|DRLB) (unless otherwise mentioned), and presentations include:
Registration and Listing Deficiency Letters
Tasneem Hussian, PharmD
Current Compliance Projects: U.S. Agents – Verification Initiative & Listing Inactivation Project
Leyla Rahjou-Esfandiary
Paul Loebach
Submission Troubleshooting Exercise
Julian Chun, PharmD
Q&A Panel (Including all above presenters):
Capt. Matt Brancazio, Office of Management’s Division of User Fee Management
Troy Cu
For slides and additional information: [ Ссылка ]
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
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