Bakul Patel

The FDA creates new Digital Health unit to reimagine regulatory paths in the age of scalable, AI-enhanced innovation

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Med­i­cine Is Going Dig­i­tal. The FDA Is Rac­ing to Catch Up (Wired):

“WHEN BAKUL PATEL start­ed as a pol­i­cy advi­sor in the US Food and Drug Admin­is­tra­tion in 2008, he could pret­ty much pin­point when a prod­uct was going to land in front of the review­ers in his divi­sion. Back when med­ical devices were heavy on the hardware—your pace­mak­ers and your IUDs—it would take man­u­fac­tur­ers years to get them ready for reg­u­la­to­ry approval. FDA review­ers could keep up pret­ty well [Read more…] about The FDA cre­ates new Dig­i­tal Health unit to reimag­ine reg­u­la­to­ry paths in the age of scal­able, AI-enhanced innovation