Medical technology is advancing faster than ever, but many lifesaving devices often face years of regulatory hurdles before reaching patients. The FDA’s Breakthrough Devices Program is designed to change that, offering innovators a faster pathway to market while maintaining rigorous safety standards. With over 1,100 designations and 160 authorizations to date, this program is transforming … Read more
In cancer research, nothing is more important than proving whether a treatment helps patients live longer. That’s why “overall survival” (OS) is considered the gold standard in oncology trials—it’s clear, objective, and clinically meaningful. The FDA’s new draft guidance sheds light on how sponsors should design, analyze, and report OS data to ensure that cancer … Read more
Twenty years ago, U.S. politics—not science—slammed the brakes on embryonic stem cell research, delaying lifesaving breakthroughs for a generation. Now, the same playbook is being dusted off—this time targeting mRNA vaccine technology, the very innovation that helped save hundreds of millions of lives during COVID-19. If history is any guide, this short-sighted decision will cost … Read more
Imagine walking out of your doctor’s office with a grocery list and a cooking plan instead of another prescription. At UT Southwestern Medical Center, that’s exactly what’s happening. Through a pioneering culinary medicine program, doctors and dietitians are teaching patients how to cook their way to better health—and the results are turning heads in the … Read more
Investing in quality management isn’t just about regulatory compliance; it’s a strategic move that boosts efficiency, profitability, and public health outcomes. An FDA white paper presents a systematic analysis of how mature quality systems can provide both economic and public health benefits to the industry. There are no surprises in the paper; it provides the … Read more
Observational studies play an important role in medicine by providing insights not available from controlled clinical trials, but many suffer from poor transparency and inconsistent methods. Their potential is often compromised by bias, data dredging, and unverifiable conclusions. Could registering the observational studies address the concerns with their reliability and unlock their full potential to … Read more
Artificial intelligence is increasingly powering your doctor’s decisions. But as AI advice becomes a staple in modern healthcare, a surprising trend is emerging: patients aren’t quite ready to trust it. Artificial intelligence (AI) is making its mark on healthcare, offering unprecedented support in diagnostics, treatment planning, and even behind-the-scenes administrative work. But new research reveals … Read more
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
