Day: February 26, 2026

For nearly a decade, basic scientists have wrestled with a classification that felt like a square peg in a round hole: the BESH designation. By labeling fundamental human behavior studies as “clinical trials,” the NIH sparked years of debate over administrative burden versus scientific transparency. Now, a massive policy shift is officially on the horizon, … Read more

The standard regulatory threshold of “substantial evidence of effectiveness” has historically relied on large-scale randomized controlled trials (RCTs) to mitigate statistical noise. For ultra-rare genetic conditions, however, the laws of small numbers make traditional RCTs practically and ethically unfeasible. The FDA’s latest guidance introduces a “Plausible Mechanism Framework” to bridge this gap, allowing deep molecular … Read more