FDA & ICH
Ethics in Clinical Research
The FDA Accepts ICH E11A on Pediatric Extrapolation: How Does This Impact Your Pediatric Study?
Blog Posts
FDA & ICH
Sunsetting FDA Enforcement Discretion of Laboratory Developed Tests
Blog Posts
FDA & ICH
Function over Form: Assessing Different Consent Form Formats
Whitepapers
Ethics in Clinical Research
Research and Cannabis: Ethical Research in a Changing Regulatory Landscape
Whitepapers
Ethics in Clinical Research
What Can Institutions with Local IRBs Do to Prepare for the Proposed FDA Single IRB Mandate?
Whitepapers
Ethics in Clinical Research
Reviewing the FDA’s Proposed Informed Consent Rule Changes
Whitepapers
Ethics in Clinical Research
Understanding the FDA’s new proposed regulations on human subject research and their impact on your clinical trial plans
Videos
FDA & ICH
Assessing Potential Risks in the Consideration of IND Exemption Criteria
Blog Posts
Ethics in Clinical Research
Defining “Minimal Risk” in Clinical Research
Blog Posts
Ethics in Clinical Research