Companies directly and indirectly regulated by the U.S. Food and Drug Administration (FDA) face specific challenges separate from other businesses in dealing with the recent outbreak of coronavirus disease 2019 (COVID-19).
The FDA has not offered specific recommendations on measures that regulated industries should take. However, good manufacturing practice requirements and the Federal Food, Drug and Cosmetic Act impose obligations on regulated industry to monitor and control employee health and sanitation practices as they relate to product quality and safety. Beyond the risk of state and federal enforcement, there are reputational risks associated with inadequate management of COVID-19.
Husch Blackwell’s FDA team will walk you through the current state of the outbreak and what you need to know to effectively manage your response to COVID-19.
Presenters
Seth A. Mailhot, Partner
Tamar E. Hodges, RN, Attorney
Emily R. Lyons, Attorney
Who Should Attend
Business owners, CEOs, CFOs, vice presidents, directors, regulatory personnel, human resource professionals, general counsel and other in-house counsel at FDA-regulated companies.
Questions?
Contact Morgan Buciumean at 303.749.7281.
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