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Q&A: What Do FDA’s Recent Medical App Approvals Mean For Industry?

 
• By Elizabeth Orr

Marc Scheineson, a former US FDA associate commissioner who now heads Alston & Bird’s food and drug law practice, offered insight into the agency's latest moves in regulating medical apps and what industry should watch for.

Interview

Medical app regulation has been a rapidly changing field and area of focus for US FDA over the last several years. Most recently, the agency approved the first direct-to-consumer app-based contraceptive, Natural Cycles, from Natural Cycles Nordic AB. (Also see "FDA Approves Birth Control Mobile App, Vaginal Ring " - Medtech Insight, 10 August, 2018.)

Medtech Insight spoke to Marc Scheineson, an attorney and FDA vet who heads Alston & Bird’s food and drug law...

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