FDA & ICH

The FDA Accepts ICH E11A on Pediatric Extrapolation: How Does This Impact Your Pediatric Study?

Sunsetting FDA Enforcement Discretion of Laboratory Developed Tests

Understanding the FDA’s new proposed regulations on human subject research and their impact on your clinical trial plans

Assessing Potential Risks in the Consideration of IND Exemption Criteria

Defining “Minimal Risk” in Clinical Research

What are the requirements for notifications of study closure at research sites?

The Basics of the Individual Expanded Access Request Process: A Resource for Physicians

Key Takeaways From FDA’s New Draft Guidance, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”

Can a physician submit a single humanitarian use device (HUD) submission to the IRB?

When should a child assent form be used in a pediatric clinical trial?