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
Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Service, http://www.fda.gov/cder/regulatory/applications/ind_page_l.htm#Intraduction, Investigational New Drug (IND) Application Process (Accessed 19 January 2008).
Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Service, http://www.fda.gov/cder/handbook/clinhold.htm, Clinical Trial Hold (Accessed 19 January 2008).
Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Service, 312.23 Code of Federal Regulations.
Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Service, History of the FDA. The 1938 Food, Drug, and Cosmetic Act, http://www.fda.gov/oc/history/historyoffda/section2.html (Accessed 9 March 2008).
Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Service, New Drug Development and Review Process, http://www.fda.gov/cder/regulatory/applications/NDA.htm (Accessed 9 March 2008).
Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Services, Refuse to File Letter, http://www.fda.gov/cder/handbook/refusegn.htm (Accessed 9 March 2008).
Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Services, Guideline for the Format and Content of the Clinical and Statistical Sections of an Application, July 1988.
Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Services, Comprehensive Table of Headings and Hierarchy, http://www.fda.gov/Cder/regulatory/ersr/5640CTOC-vl.2_OnlinePDF.pdf (Accessed 29 February 2008).
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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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