Last April, in what can only be described as a mic-drop moment for clinical laboratories, a federal judge in Texas struck down the FDA’s bold (and arguably baffling) move to reclassify laboratory-developed tests (LDTs) as medical devices. It was a legal slapdown decades in the making—and the FDA didn’t even bother to appeal. The deadline … Read more
The FDA just unveiled its own AI assistant, Elsa, designed to turbocharge safety reviews and regulatory workflows. But behind the polished launch is a growing debate: is Elsa a groundbreaking partner, or an overhyped experiment not ready for real work? The U.S. Food and Drug Administration has officially stepped into the AI era with the … Read more
The FDA is drawing a hard line on drug approvals, questioning whether single-arm trial data is enough to back a new bladder cancer treatment. As pressure mounts to approve faster, the agency fears lowering the bar could set a risky precedent for future cancer therapies. The case in point, whether a new bladder cancer treatment, … Read more
Artificial Intelligence is reshaping medicine faster than ever before. With nearly 1,000 FDA-approved AI-enabled devices already on the market, the question isn’t if AI will revolutionize healthcare—it’s whether we’re ready for it. A new study from JAMA Network Open delivers a sobering reality check on the clinical rigor behind these innovations, and what’s missing might … Read more
Is animal testing still necessary for drug development in the 21st century, or has cutting-edge technology made it obsolete? As the FDA begins shifting toward human-relevant models, the debate over eliminating animal testing is heating up like never before. For decades, animal testing has been an entrenched part of drug development. Most life-saving medicines from … Read more
A new NIH-CMS partnership promises to use electronic medical records (EMRs) and real-world data (RWD) to answer complex questions about autism and other chronic diseases. Experience in the last decade has shown several limitations of the real world data relying of which could lead to dangerous policy missteps, misleading health research, and wasted billions, especially … Read more
The U.S. Food and Drug Administration (FDA) is fast-tracking the integration of artificial intelligence across its scientific review processes, signaling a transformative shift in how new therapies are evaluated and approved. Following the successful completion of an internal pilot using generative AI tools, the agency is now moving aggressively toward full deployment of these technologies, … Read more
Do we need fewer regulations? Who should point out which ones should go? Who is the target of this reduction in regulation, the industry or the healthcare community? The U.S. Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) announced a major new initiative this week whereby the public can … Read more
The FDA audits, particularly the unannounced or surprise inspections, are critical to ensure the integrity of the global drug supply chains. Unannounced FDA inspections at foreign facilities pose unique logistical, legal, and cultural challenges, leading to most foreign audits being announced weeks before they occur. This week, the FDA announced that it will expand unannounced … Read more
The executive order signed by President Donald J. Trump to promote American-made prescription drugs addresses a real and pressing issue. However, it oversimplifies the economic and structural factors behind the offshoring of drug manufacturing and misrepresents the nature of what kinds of pharmaceuticals are produced abroad versus domestically. The decision-making process for pharmaceutical manufacturing is … Read more
