US FDA Rebukes Another Sponsor For Touting Investigational Product Based On Subgroup Efficacy

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.