Draft guidance describes evidence needed to support qualification of a biomarker for use in drug development programs.
The US FDA's draft guidance advising sponsors what information is needed to support qualification of a biomarkers suggests sponsors could aim to gradually widen their use in drug development as more evidence becomes available.
The guidance, Biomarker Qualification: Evidentiary Framework Guidance for Industry and FDA Staff, identifies the recommended components of a biomarker...
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
