Latest From Brenda Sandburg
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.
CBER director Peter Marks notes efforts to bring in more staff to deal with ‘crushing’ workload; says there has been no political pressure for the center to approve COVID-19 booster shots.
Warning letter from agency for conducting clinical studies in COVID-19 patients without filing IND follows Kaleido decision the product could be designated as a food and thereby bypass an investigational new drug application.
US regulators set public workshop on benefits, challenges, and unintended consequences of making REMS education program mandatory. Having a single source for education is also being evaluated. Agency has previously been concerned that a mandatory program might require a restricted distribution system.