DECEMBER 07, 2022
2:45 PM — 3:45 PM


When a company receives a warning letter, the first (and most discussed) priority is responding to FDA's concerns. However, what is frequently overlooked are the secondary impacts of receiving a warning letter, especially a warning letter setting forth GMP violations. These impacts can include product related litigation, recalls, loss of customer trust, increased oversight by third parties, impacts on current or future due diligence, and harm to company reputation. This session will discuss strategies for addressing these secondary impacts.

Foley Hoag Partner and FDA Practice Co-Chair Areta Kupchyk will join the Food and Drug Law Institute (FDLI) for this panel discussion during FDLI's "Enforcement, Litigation, and Compliance Conference." Foley Hoag is also proud to sponsor this event.