Author: Kathryn Madalena

FDA | Healthcare AI | Healthcare innovation | Regulatory Compliance

Navigating the Regulatory Landscape of Prescription Digital Therapeutics (Part 2)
ByKathryn Madalena September 10, 2025

In our first installment, we explored the rapidly evolving world of digital health therapeutics (DTx),1 which are innovative, evidence-based software solutions that go far beyond wellness apps to deliver clinically meaningful outcomes for patients. We discussed the distinctions between prescription and non-prescription DTx, highlighted real-world examples, and discussed the significant benefits DTx offer in terms…

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Advisory Committees | FDA | ProEd Regulatory

AdComs: They Are a-Changin’
ByKathryn Madalena February 13, 2024September 9, 2025

Changes Are Coming to Advisory Committee Meetings Advisory Committee meetings (AdComs) are a long-standing feature of the FDA drug approval process. How and where those meetings are conducted has been evolving over the past few years, since the introduction of virtual meetings, and even more considerable reforms may be coming sooner rather than later. According…

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