Brenda Sandburg
Latest From Brenda Sandburg
Improper Dose In Phase II Trials Can ‘Make Or Break’ Drug Program, FDA’s Stein Says
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.
Some US FDA Advisory Committee Meetings Likely To Remain Virtual Post-Pandemic
Peter Stein says FDA will set criteria for holding a virtual meeting and will be seeking stakeholder feedback.
US FDA’s Stein ‘Excited’ About Real-World Evidence, Rare Disease Endpoint Pilot Programs
Head of Office of New Drugs highlights programs being established under PDUFA VII that could help overcome obstacles in drug development.
Remote Working May Help Delay Retirement Of Senior US FDA Officials
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.
Kaleido Anticipated Potential Conflict With US FDA Over Its Microbiome Therapy Product
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.
Opioid Prescriber Education Program May Become Mandatory; FDA Cites Failures In Voluntary System
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.