Heidi Forster Gertner

On June 22, 2026, HHS unveiled Operation TrialBlazer, a coordinated initiative to keep early-stage clinical research in the United States. Two developments matter most for pharmaceutical manufacturers: (1) a package of FDA...more The U.S. Food and Drug Administration (FDA) announced a “real-time clinical trials” (RTCT) pilot program to permit agency reviewers to review study data simultaneously with its collection by investigators. FDA also issued an...more FDA recently issued new guidance for industry, Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization, describing its current enforcement intentions with respect to electronic...more The U.S. Food and Drug Administration (FDA) announced a “real-time clinical trials” (RTCT) pilot program to permit agency reviewers to review study data simultaneously with its collection by investigators. FDA also issued an...more