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Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017

Kevin B. Bugin provides an introduction to Investigational New Drug Applications, including what the application is and role of the application in clinical trial regulation. He discusses the circumstances in which the application is needed, the different categories and types of applications. And finally, the presentation will share information on the pre-IND consultation program and shed light on the internal review processes involved in FDA’s initial IND safety review. ------------------------- 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 and free continuing education credits: https://www.fda.gov/cdersbia CDER SBIA 2017 Playlist:    • 2017 CDER Small Business and Industry...   LinkedIn:   / cder-small-business-and-industry-assistance   Training resources: https://www.fda.gov/cderbsbialearn Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... Email: [email protected] Phone: (301) 796-6707 I (866) 405-5367