In a June 16, 2020, blog, USP discusses recent FDA regulatory guidances for digital therapeutics, regulated as medical devices, here. Since 2018, USP, along with the Digital Therapeutics Alliance (DTA) has been looking at the potential role(s) of USP in the Digital Therapeutics (DTx) field. Now, USP has released a white paper on quality standards for DTx.
Find the 13-page white paper here. USP plans a roundtable in Fall 2020.
There are close interactions between digital therapeutics and pharma. See McKinsey on this here. Rock Health here. Business Insider here. For a headline this week, the pharmacy benefit manager or PBM, RemedyOne, offers a channel for access to Pear Therapeutics DTx (June 24 article here).
