Module 1 2021

IND  Clinical Trial/Program Initiation Investigational New Drug (IND) Application • An IND to test the diagnostic or therapeutic potential of an investigational new drug/biological in a clinical investigation − New Chemical Entity (NCE) − Approved Drug • New indication • Unapproved doses • New dosage form • Change in route of administration • Change in dose regimen • IND: Described in 21 CFR Part 312 (Investigational New Drug Application) • Pre-IND Meeting: Opportunity to have early discussion with FDA on your product, the preliminary development plan and any issues you would like to obtain guidance/advice – Nonclin, CMC, Clin, Reg

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What is an IND?

• Document through which the drug sponsor alerts the FDA of its intention to conduct clinical studies with an investigational drug. − Summation of data to support clinical exposure for drug not previously authorized for marketing in the U.S. − Promise of compliance and to do no harm • In legal terms, the IND is a request for an exemption from the federal statue that prohibits an unapproved drug from being shipped in interstate commerce

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