10 min. read

Analysis: FDA’s new guidance for digital therapeutics

Issue 048.

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Digital health research from Brian Dolan.

Welcome to E&O.

Last week's newsletter had a 59 percent open rate. Here's what's happening this week:

  • As part of the effort to make virtual care more accessible during the COVID--19 pandemic, the FDA posted a new enforcement guidance focused on digital health devices for the treatment of psychiatric disorders. Given how many DTx companies are focused on behavioral health, this move by the FDA has a lot of companies re-examining their go-to-market timeline. I pushed back the MSK report a few days as I've been on the phone with readers non-stop trying to getting my head around this guidance. Read more on the FDA's in today's top story below...
  • Decisions Resources Group has a worthwhile report out on payers' perspectives around digital therapeutics that is based on responses from 157 P&T committee members at

Paying Subscribers Only

It's a good one, too.
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