COVID-19: FDA Regulatory/Life Sciences

As part of its oversight of medications and medical devices utilized in the fight against COVID-19, the FDA has enacted its Emergency Use Authorization (EUA) authority to help strengthen the nation’s public health protections by facilitating the availability and use of urgent medical countermeasures. Our Life Sciences attorneys have first-hand experience advising corporate clients on how to navigate the EUA and obtain the necessary clearances from the FDA to assist the medical community in treating COVID-19 patients. The federal government has also expanded the Public Readiness and Emergency Preparedness (PREP) Act to include a countermeasure aimed at responding to COVID-19, and it has enacted the Families First Coronavirus Response Act, which includes a provision aimed at incentivizing mask producers to increase the supply of available personal protective equipment (PPE) for medical professionals fighting the virus by granting such manufacturers immunity from lawsuits that may arise as a result of providing such equipment. Our attorneys are poised to answer any questions business may have about these new laws and regulations. Additionally, working with other practice groups in Lewis Brisbois’ nationwide team, we are able to provide guidance on how companies can modify their existing business models to facilitate the importation and distribution of key supplies such as respirators, medicines, and PPE. Our experienced attorneys are available immediately to answer your questions and evaluate your particular business’ options.