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.
The FDA Rare Disease Framework Initiative Explained
The FDA Rare Disease Framework Initiative aims to make rare disease drug review more consistent. Explore the six commitments and what sponsors should do now.
FDA’s NAIN Programme for Alzheimer’s Prevention
The FDA’s new NAIN programme launches with the Alzheimer’s Prevention Accelerator. Explore the implications for clinical trials, biomarkers, and development strategy.
CRA-CRC Training for Closing the Sponsor-Site Gap
CRA-CRC training can rebuild sponsor-site trust that remote monitoring weakened. Find out what a 2026 study found and how clinical teams can act on it.
Clinical Trial Changes and Protocol Amendments
Protocol amendments can rescue studies or weaken evidence. Learn how sponsors can distinguish justified adaptation from costly drift in clinical development.