Abstract
The purpose of an Investigational New Drug Application (IND) is to demonstrate that a product is reasonably safe for first-time use in humans. Several types of INDs exist, based on who is submitting (Investigator IND versus an IND submitted by a sponsor); the urgency of use of the investigational drug (Emergency use IND or Treatment IND); or the regulatory strategy (traditional IND versus Exploratory IND). This chapter describes a traditional IND, the most commonly used type and the IND most regulatory writers will prepare.
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References
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© 2009 Birkhäuser Verlag Basel/Switzerland
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Wood, L.F. (2009). Region-specific submissions: United States of America. In: Wood, L.F., Foote, M. (eds) Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics. Birkhäuser, Basel. https://doi.org/10.1007/978-3-7643-8362-6_13
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DOI: https://doi.org/10.1007/978-3-7643-8362-6_13
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