The introduction of a new medicinal product to the US market follows a complex process that may extend many years from the initial discovery through to the US Food and Drug Administration (FDA) approval and market launch. There are many factors during the product development that impact the success of drug approval and launch, a thorough understanding of the regulations and requirements is often underrated. The drug development process is becoming increasingly specialized and the regulatory pathway that works for one program may not work or be applied to another program for the same indication.
In this webinar, we talk about:
What does it mean to “Begin with the End Goal in Mind?”
What information should an Investigational New Drug (IND) Application contain?
How to communicate with FDA as your partner
What are the FDA’s expedited programs?