RENAISSANCE DOWNTOWN HOTEL
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.