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Cyber threats can present a direct risk to patient lives. The FDA’s updated 2025 guidance on cybersecurity in medical devices emphasizes, with templates and examples, the importance of cybersecurity considerations from the first line of code. The new guidance adds on to previous guidances to outline the FDA’s expectations from what manufacturers must do to … Read more

Is the FDA protecting American patients—or playing politics with science? Informed consent rules already safeguard the use and export of human biological materials, yet the agency’s new halt on international cell engineering trials suggests a politically charged narrative that paints foreign labs as threats to U.S. security, rather than collaborators in global innovation. In a … Read more

What happens when the pillars of America’s scientific and regulatory powerhouses, the FDA and NIH, are shaken to their core by political overreach? Amid the chaos and cuts, a surprising opportunity is emerging: the rise of a bold, independent R&D movement that could transform the future of medicine. In a one-two punch that has rocked … Read more

The FDA just called out another non-IND clinical trial with a supplement claiming medical benefits. An FDA inspection revealed that the sponsor of a Relaxium® Sleep study bypassed critical regulatory steps, raising serious concerns about participant safety and data integrity in unapproved clinical trials. In a Warning Letter to the American Behavioral Research Institute (ABRI), … Read more

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