FDA Commissioner Margaret Hamburg posted an “FDA Voice” blog
piece in early April to praise the persistent advocacy efforts in the search for treatments for Alzheimer’s disease—if not the...
FDA recently featured an Alzheimer’s Disease clinical trial simulation tool as another positive, but low-visibility, step toward improving the drug development pathway for the disease. The process for accepting the tool may be as important as the tool itself.
FDA Commissioner Margaret Hamburg posted an “FDA Voice” blog
piece in early April to praise the persistent advocacy efforts in the search for treatments for Alzheimer’s disease—if not the...
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
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.
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.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.