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Clinical Trials Are A Regulatory Danger Zone for Unregulated Wellness Apps, BioWorld

November 12, 2021

During a recent Food and Drug Law Institute webinar on the developments in digital health regulations, covered by BioWorld, partner Michele Buenafe said that most developers of digital health apps exercise regulatory due diligence.

However, the explosion of interest in the field suggests the number of bad actors will increase, she noted—even if their proportional representation remains flat. Michele said that while this could increase the volume of enforcement activity, companies would also benefit by more regulatory clarity.

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