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FDA's Prescription Drug Use Related Software Guidance Advances To OMB
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Fusion42 · 22 September 2026 · Fusion42 review
The FDA's Prescription Drug Use Related Software (PDURS) guidance has been advanced to the White House Office of Management and Budget (OMB) for review, with support from the American Telehealth Association advocating for regulatory easing of certain digital health tools linked to drug labeling.
This Wire brief sits within Fusion42's coverage of Digital Health.
◆ ◆ The Wire takeaway
You face a new path to market for digital health tools paired with prescription drugs as the FDA moves to reduce regulatory barriers. This window lets you accelerate development and partnership moves before final rules lock in.
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1 source · 22 Sep 2026
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