FDA Expedited IND Pilot Targets Faster First-In-Human Trials
The FDA’s Expedited IND Pilot introduces rolling review and sponsor-QRI partnerships to accelerate Phase I first-in-human trials while retaining regulatory oversight.
FDA Non-Animal Testing Policy Expands Nonclinical Options
FDA non-animal testing policy expands the regulatory role of nonclinical methods and introduces 25 NAM use cases for pharma development teams.
Overton FDA Hearing Tests Scientific Independence
Heidi Overton's FDA confirmation hearing exposed sweeping advisory committee cuts, tobacco industry ties, and unclear stances on vaccines and mifepristone policy.