Although guidance appears to be free of surprises, US FDA once again made a push for sponsors to adopt seamless trial designs.
As US FDA Commissioner Scott Gottlieb has touted the use of seamless clinical trial designs, the agency appears to promote the concept in a new draft guidance on developing drugs for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
In the guidance published Dec. 3 that otherwise contains mostly expected information, the agency says that, "Sponsors could use...
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.
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.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
