Day: September 11, 2025

The release of ICH E6(R3) marks a transformative shift in global clinical trial standards. By embracing risk-based quality management, modern technologies, and flexible trial designs, this guideline redefines how research should be conducted while safeguarding participants and ensuring reliable results. For sponsors, investigators, and regulators alike, E6(R3) represents a milestone in harmonizing innovation with patient … Read more

A prominent blogger highlighted the hypocrisy in the FDA’s latest crackdown on pharmaceutical advertising, which claims to combat deception. But under the current laws and the political environment, what are the practical options to respond for the affected parties? The unprecedented FDA move is based on questionable studies and data. Instead of protecting patients, this … Read more