From regulatory strategy to quality systems and product commercialization, our experts share practical guidance to help medical device, pharmaceutical, and biotech companies accelerate compliance and reduce risk.
From IND-Enabling Work to First-in-Human: What FDA’s Expedited IND Pilot Says About Integrated Drug Development. In September 2026, the U.S. Food and Drug Administration launched its Expedited Investigational New Drug Pilot Program, an initiative under HHS Operation TrialBlazer designed to evaluate new approaches for accelerating first-in-human clinical trials in the United States while maintaining FDA standards for participant safety and scientific oversight.
On September 28–29, 2026, the European Medicines Agency (EMA), together with partners in the European Medicines Regulatory Network, convened a multi-stakeholder workshop dedicated to women’s health. The meeting brought together regulators, patients, healthcare professionals, academia, industry, and global partners to examine existing evidence gaps, identify research priorities, and consider opportunities to strengthen medicines development and clinical research.
