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FDA Releases Draft Guidance On Use Of Real-World Evidence For Drug Biological Products

The FDA has issued new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data (RWD) and. ....

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What New FDA Policy Means For COVID Tests And Beyond

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. ....

Stacy Amin , Us Department Of Health , Human Services , Drug Administration , Bethany Hills ,

Preeminent Patent Prosecutor Hogene Choi Joins Morrison & Foerster's Market-Leading Life Sciences Team

Preeminent Patent Prosecutor Hogene Choi Joins Morrison & Foerster's Market-Leading Life Sciences Team
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Global Healthtech CEO Connect: Software As A Medical Device In The U.S. And EU Recap | MoFo Life Sciences

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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. ....

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