Expedited Approvals, the Regulatory Impacts, and FDA’s Long Term Strategy
With the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are facing EUA problems keeping their supply chains intact. In this episode of RCA Radio, host Erika Porcelli and guests Susan Schniepp, Regulatory Compliance Associates (RCA) Distinguished Fellow and Parental Drug Association (PDA) Chair-Elect, and Lisa Michels, RCA’s General Counsel & Regulatory Affairs Expert, continue to discuss the regulatory impacts with Emergency Use Authorizations as well as how to address and try to overcome the new distancing regulations put in place to combat the spread of Covid-19.
Listen in as we go over EUA expedited approvals and relevant regulatory impacts as well as the FDA’s long term inspection strategy moving forward.
For full transcript click here.
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