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In a reversal of Trump administration policy, the U.S. Food and Drug administration will soon require premarket review of laboratory-developed tests for COVID-19 and other diseases, throwing test makers into a position of regulatory uncertainty that will likely be resolved through litigation or legislation, say Stacy Amin and Bethany Hills at MoFo.
Preeminent Patent Prosecutor Hogene Choi Joins Morrison & Foerster's Market-Leading Life Sciences Team prweb.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prweb.com Daily Mail and Mail on Sunday newspapers.
To embed, copy and paste the code into your website or blog: On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific use cases for digital therapeutics and other digital health products. Speakers included Morrison & Foerster partners Bethany Hills and Wolfgang Schönig as well as special guest Corey McCann, president and CEO of Pear Therapeutics, in a fireside chat at the end of the program. Globally, the convergence of software technology and life sciences creates a massive opportunity for growth, and the market for these products is growing exponentially. Both the U.S. Food and Drug Administration (FDA) and European regulators have focused on establishing a regulatory framework for oversight of SaMD.