FDA initiative aimed at optimizing cancer drug dosage earlier in development started with single-agent therapies, but moving into combinations is ‘a natural progression,’ Oncology Center of Excellence’s Richard Pazdur says. At a recent workshop, experts discuss considerations for combination product dosage optimization and review case studies that reflect Optimus principles.
The US Food and Drug Administration’s Project Optimus, which has changed how sponsors approach dosage optimization for single-agent oncology agents, is coming to combination therapies.
During a recent two-day workshop sponsored by the agency and American Society of Clinical Oncology, FDA officials made clear that sponsors should be prepared to apply the principles of Project...
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
