Biden’s Pandemic Preparedness Plan Targets Vaccine Design, FDA Regulatory Approaches
Administration proposal is long on ambition, short on details; goals are to confront future pandemics, including improving vaccines and therapeutics, manufacturing capacity and supply chains.
You may also be interested in...
Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.
Peter Stein says FDA will set criteria for holding a virtual meeting and will be seeking stakeholder feedback.
Head of Office of New Drugs highlights programs being established under PDUFA VII that could help overcome obstacles in drug development.