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Regulatory and Administrative Components of an IND Application (5/14) REdI 2017

Maureen Dillon-Parker provides an overview of the contents and format of the Investigational New Drug Application (IND), including a discussion of the regulatory and administrative components as well as the preclinical, product quality and clinical components. ------------------------- 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