FDA regulatory partner and practice chair Greg Levine (Washington, D.C.) presented at the Food and Drug Law Institute’s webinar on April 14 titled “FDA’s Recent COVID-19 Guidances Facilitating Expanded Access to Certain Medical Products.”
The FDLI webinar attracted a record-breaking attendance of more than 1,100 participants from traditional FDA-regulated companies and those outside the FDA purview seeking advice during the COVID-19 pandemic.
The U.S. Food and Drug Administration recently issued an array of COVID-19- related guidance documents that aim to facilitate expanded availability of certain medical products during the current public health emergency through enforcement discretion and other temporary policies. These products include diagnostics, personal protective equipment, remote monitoring devices, ventilators, disinfectant devices, and hand sanitizers. The webinar examined the scope of these guidances, their impact on regulated companies, and how they relate to other FDA requirements, such as Emergency Use Authorizations.
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