FDA & ICH
CenterWatch | Insights
The FDA Accepts ICH E11A on Pediatric Extrapolation: How Does This Impact Your Pediatric Study?
Blog Posts
CenterWatch | Insights
Sunsetting FDA Enforcement Discretion of Laboratory Developed Tests
Blog Posts
CenterWatch | Insights
Understanding the FDA’s new proposed regulations on human subject research and their impact on your clinical trial plans
Videos
CenterWatch | Insights
Assessing Potential Risks in the Consideration of IND Exemption Criteria
Blog Posts
CenterWatch | Insights
Defining “Minimal Risk” in Clinical Research
Blog Posts
CenterWatch | Insights
What are the requirements for notifications of study closure at research sites?
Blog Posts
CenterWatch | Insights
The Basics of the Individual Expanded Access Request Process: A Resource for Physicians
Whitepapers
CenterWatch | Insights
Key Takeaways From FDA’s New Draft Guidance, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”
Blog Posts
CenterWatch | Insights
Can a physician submit a single humanitarian use device (HUD) submission to the IRB?
Blog Posts
CenterWatch | Insights