Overview: This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market. We will begin by reviewing the contents of an Investigational New Drug (IND) application, and then follow the process of an IND submission. Next, the contents and approval process of an NDA submission will be discussed. […]
Which GMPs Apply Since Most Phase I Drugs are Exempt from Full GMP Requirements, and What IND Data Requirements Are Necessary as a Result?