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Unlocking the Potential of Digital Health Therapeutics: FDA-Approved Solutions for Modern Healthcare

ByJackie Orabone

Digital health therapeutics (DTx), applications increasingly powered by AI and/or machine learning, are on the rise and promise to increase access to healthcare, provide real-time monitoring of health data, improve patient engagement and adherence to treatment, and reduce healthcare costs. What Are Digital Health Therapeutics? DTx are evidence-based therapeutic interventions driven by software and technology…

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From Pilot to Policy: The FDA’s Rapid March Toward AI-Powered Drug Reviews

ByAaron Csicseri

When FDA reviewers discovered that a generative-AI pilot could slash a 3-day document review task to mere minutes—a time-savings of 99%!—it became clear that artificial intelligence is no longer an aspirational tool but a present-day catalyst for regulatory transformation. That single statistic captures why FDA is fast-tracking AI: the volume and complexity of regulatory submissions…

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New FDA Guidance on the Use of AI to Support Regulatory Decisions

ByAaron Csicseri

The US Food and Drug Administration (FDA) has just taken a historic step by releasing its first-ever draft guidance on using artificial intelligence (AI) for regulatory decision-making related to the safety, effectiveness, or quality of drugs and biologics.1 Published in January 2025, this framework comes at a pivotal time, as AI’s potential to transform healthcare…

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AI’s Impact on Regulatory Affairs: From Data Management to Decision Making

ByAaron Csicseri

Artificial Intelligence (AI) is significantly transforming pharmaceutical regulatory affairs. Rather than replacing regulatory professionals, AI enhances their capabilities and allows them more time for strategic activities. This blog post explores how AI is revolutionizing the regulatory submission process, the challenges posed by the rapidly evolving AI regulatory landscape, and what regulatory affairs professionals need to…