Day: February 19, 2026

Keeping pace with the rapid evolution of medical technology requires a regulatory framework that is both rigorous and agile. The FDA’s latest announcement regarding the Food and Drug Administration Modernization Act of 1997 represents a vital step in aligning regulatory expectations with modern engineering. By updating its list of recognized consensus standards, the agency is … Read more

The FDA’s transition to a single-trial default for drug and biologic approvals marks a pivotal evolution in regulatory philosophy, moving away from the 1962 Kefauver-Harris dual-study precedent. For industry leadership, this shift offers a significant opportunity to accelerate speed-to-market, provided that clinical programs are built on a foundation of absolute statistical and biological rigor. However, … Read more