Real-world data is being hailed as the next big thing in clinical research, but the reality is a bit messier. Until we clean up the data and rethink how we collect it, real-world evidence risks being a shiny promise with little power. The explosion of electronic health records (EHRs) and digital claims databases was supposed … Read more
Two-to-one (2:1) randomization has become a common feature in clinical trial design, particularly in oncology, often under the belief that it helps recruit more patients by increasing the chances of receiving the experimental treatment. But according to Freidlin and Korn in their recent JCO Oncology Practice article, this practice may be more problematic than promising. … Read more
In a sweeping regulatory shift that’s already sending shockwaves through the global supply chain, the U.S. Food and Drug Administration (FDA) has officially revoked the longstanding exemption for low-value imports. As of July 9, every shipment of FDA-regulated products—regardless of its dollar value or size—must now undergo full FDA review. This marks the end of … Read more
Antibacterial therapies targeting serious infections in patients with limited or no therapeutic options are hard to develop for scientific, logistical, and financial reasons. FDA’s latest guidance describes the FDA’s expectations for developers of antibiotics for patients with an unmet medical need for a serious bacterial infection. The guidance articulates a science- and risk-based framework for … Read more
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
