One weird thing that’s been holding drug trials back

For more than 60 years, this blank slate approach has been the Food and Drug Administration’s gold standard — and for good ...

Professor Sarfaraz Niazi's Scientific Framework Adopted as FDA Modernizes Clinical Trial Evaluation Through Bayesian Methods

The U.S. Food and Drug Administration (FDA) has issued new draft guidance modernizing statistical methodologies used in ...
JD Supra

FDA Issued Updated Patient-Focused Drug Development Guidance on Clinical Outcome Assessments

The U.S. Food and Drug Administration (FDA) issued its third Patient-Focused Drug Development (PFDD) guidance titled, “Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments ...

Trump’s Drug Pricing Proposals Draw Legal Questions From Pharma

The Trump administration’s plan to lower US drug costs through two new pricing models is prompting legal concerns from the ...
ascopubs.org

Impact of Food and Drug Administration Project Optimus Guidance on Design of Early-Phase Clinical Trials

Recent Trends and Patient Outcomes of Phase I Trials: A Single-Institution Experience in the Era of New Therapeutic Agents This study reviewed all industry-sponsored phase I clinical trial protocols ...
Pharmabiz

US FDA issues guidance on modernizing statistical methods for clinical trials

US FDA issues guidance on modernizing statistical methods for clinical trials: Maryland Wednesday, January 14, 2026, 09:00 Hrs [IST] The US Food and Drug Administration today publ ...