Original Air Date: January 19, 2021
Expanding on the Intermediate FDA Regulation session, this Advanced session is a deeper dive into how the FDA enforces its regulatory authority over pharmaceutical medical device, biology, and dietary supplement companies. You may have an insured that received a warning letter from the FDA. What does this mean for your insured? We will discuss various enforcement actions, with the backdrop of how you can be a value-added risk management and insurance partner for your insured in this process.