Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017

Kevin B. Bugin provides an introduction to Investigational New Drug Applications, including what the application is and role of the application in clinical trial regulation. He discusses the circumstances in which the application is needed, the different categories and types of applications. And finally, the presentation will share information on the pre-IND consultation program and shed light on the internal review processes involved in FDA’s initial IND safety review.
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