A team led by Dalhousie University researchers examined 174 novel approvals from 2011-2015 and found 155 instances of disagreement, affecting 42 drugs.
The parameters of new drug approvals – including risk management and labeling – were the most common source of disagreements between US Food and Drug Administration staff during reviews of novel agents, according to analysis led by researchers at Dalhousie University in Nova Scotia.
The study, published in the American Medical Association’s open access journal JAMA Network Open on 24 July, examined the FDA...
George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.
The European Medicines Agency has started reviewing for potential EU marketing approval six new products, including MaaT Pharma’s microbiota therapeutic for acute-graft-versus-host disease, and AstraZeneca's camizestrant for locally advanced or metastatic breast cancer.
The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.
US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.
