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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: Accelerated Approval Accountability

ByAaron Csicseri

On January 6 and 7, 2025, the FDA released approximately 30 draft or final guidance documents1 covering a wide array of regulatory topics, including: These guidance documents reflect priorities the FDA deems urgent, especially in light of the new administration’s efforts to alter regulatory approaches. This article will focus on the draft guidance updates to…

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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The US Food and Drug Administration (FDA) has just taken a historic step by releasing its first-ever draft guidance on using artificial intelligence (AI) for regulatory decision-making related to the safety, effectiveness, or quality of drugs and biologics.1 Published in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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Regulating Generative AI: Insights From the FDA’s First DHAC Meeting

ByAaron Csicseri

The FDA’s new Digital Health Advisory Committee (DHAC) convened for the first time on November 20-21, 2024. The topic of discussion was medical devices that rely on generative AI (GenAI) models, which hold transformative potential for healthcare but pose unique regulatory challenges. For example, how to define the device’s intended use, manage errors like hallucinations…

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Regulatory Reforms on the Horizon

ByJeff Riegel

In February 2024, we reported on anticipated changes to the format of FDA advisory committee meetings (AdComs) based on public comments from FDA Commissioner Robert Califf and other FDA officials earlier this year. Some of those changes have, indeed, come to pass—most notably, a full‑throated return to in-person AdComs at the White Oak facility in…

The First FDA-Approved NASH Treatment Arrives After Almost Half a Century in the Making

ByMuzamil Saleem

The FDA has approved Madrigal Pharmaceuticals’ Rezdiffra™ (resmetirom) for nonalcoholic steatohepatitis (NASH). The approval is a watershed event, marking a historic turning point in the long-standing quest to find an effective treatment for the millions of Americans afflicted by this devastating condition.  A targeted treatment for NASH has eluded pharmaceutical scientists for nearly a half century……

Rare Disease Day 2024

ByJackie Orabone

This year, Rare Disease Day is on February 29, 2024. Rare Disease Day is observed on the last day of February, which is the “rarest of calendar dates1 to underscore the nature of these diseases” and serves to raise awareness of rare diseases and those individuals affected by them. FDA is holding a virtual meeting2…

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AdComs: They Are a-Changin’

ByKathryn Madalena

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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FDA Convenes Experts to Address Knowledge Gaps in Noninvasive Testing for NASH

ByMuzamil Saleem

“Silent killer” is an apt description for a potentially fatal disease that progresses slowly, without any obvious symptoms in the early stages. When you couple this insidious type of pathology with a rapidly increasing prevalence, the disease is often described in terms akin to an epidemic. Nonalcoholic steatohepatitis (NASH)—a disease characterized by fat accumulation in the…