iwewlkws The FDA has officially launched a new review voucher, the Commissioner’s National Priority Voucher (CNPV), an initiative to accelerate the review timeline for new drugs and biologics. The program promises to shorten FDA review time from the current 6–12 months (under PDUFA timelines) to as little as 1–2 months. Targeting products that align with U.S. … Read more
The investigation by an independent non-government group raises serious and important questions about the FDA’s drug approval processes. It rightfully draws attention to systemic flaws, especially the increasing reliance on surrogate endpoints, the lack of timely confirmatory studies, and the real harms patients face when exposed to ineffective or dangerous drugs. However, while the facts … Read more
The National Institutes of Health (NIH) is charting an ambitious course into the future of biomedical science with its proposed institute-wide AI strategy. Framing AI as a cornerstone of future scientific advancement, the agency envisions a world where artificial intelligence evolves from simple analytics tools into fully autonomous, self-documenting AI “beings.” While the vision is … Read more
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
