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How to put together an IND application

How to put together an IND applicationJudit Milstein, Chief, Project Management Lwin, Regulatory Health Project of Transplant and Ophthalmology ProductsOffice of Antimicrobial ProductsCenter for drug Evaluation and Research301-796-1600 FDA Clinical Investigator Training CourseNovember 15, 20182 FDA DisclaimerThe views and opinions presented here represent those of the speaker and should not be considered to represent advice or guidance on behalf of the Food and drug 's Clinical Investigator Training Course 20183 Agenda Definitions and Interpretations Content and Format of initial IND submission Regulatory and Administrative Components Non-Clinical Components Clinical Components How to submit an IND What to expect after submitting an IND (first 30 days) Best Practices/FAQs Individual Patient Expanded Access IND FDA's Clinical Investigator Training Course 20184 Definitions and Interpretations(21 CFR ) investigational New drug (IND) application An application submitted to FDA if a drug (or biological product) not previously authorized for marketing in the US is intended to be used for the purposes of clinical investigation or, in certain cases, for the purposes of clinical treatment when no approved therapies are available.

Nov 15, 2018 · Investigational New Drug (IND) Application –An application submitted to FDA if a drug (or biological product) not previously authorized for marketing in the US is intended to be used for the purposes of clinical investigation or, in certain cases, for the purposes of clinical treatment when no approved therapies are available.

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