Description
The Investigational New Drug Application (IND) is a submission through which the sponsor seeks approval from the Food And Drug Administration (FDA) to conduct clinical studies with an investigational drug. This online course will give students who are, or are becoming, regulatory professionals the necessary detail and background required in order to complete and submit, for FDA approval, an IND application. An IND must contain various pieces of information covering areas such as clinical protocol, manufacturing, toxicology, drug distribution, and animal pharmacology. The application is a stepping stone that is crucial, from nonclinical all the way to clinical testing.
