Introduction

Learn how to apply regulatory concepts to ensure compliant IND submissions to the FDA. Gain insight into the regulatory background of the NDA, preparing an NDA, and postapproval activities. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.

Venue

Drug Information Association, Inc.

Drug Information Association, Inc., 800 Enterprise Rd Ste 200, Horsham, 19044, United States

Organised by

DIA

Contact information

Susan Mazak
215-442-6183
Contact us by email

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