Last week, Vinay Prasad and Martin Makary published a landmark piece in the New England Journal of Medicine announcing that the FDA’s new default standard for marketing authorization will be one adequate and well-controlled clinical trial, supported by confirmatory...
When the Supreme Court changes a legal standard, the system adjusts. When the FDA changes a regulatory default, the drug development ecosystem recalibrates. Last week’s FDA decision to make one adequate and well-controlled trial the default, supported by confirmatory...
Healthcare is changing in front of us. Data, intelligence, and clinical insight are finally converging in ways many of us have been working toward for decades. For the first time, we can begin to understand patient journeys as they actually unfold—not in fragments,...
The US Food and Drug Administration (FDA) recently published a comprehensive overview of how real-world evidence (RWE) has contributed to regulatory decision-making since 2011. The new webpage, built by the Center for Drug Evaluation and Research (CDER) and the Center...
Today marks the 5 year anniversary of Truveta. I personally am so humbled by where we are today. As I reflect back to where we were in 2020, the world was a very different place. It was a time of great uncertainty. The world was desperate for answers to a pandemic...
