Sue Sutter
Senior Editor
Latest From Sue Sutter
FDA Medical Product Communications Need More Nuance To Deter Misinformation, Experts Say
Government agencies and others need to improve their communication to a broad audience about the relative safety of vaccines, as well as current scientific uncertainty, experts said at the FDLI annual meeting.
FDA Medical Product Communications Need More Nuance To Deter Misinformation, Experts Say
Government agencies and others need to improve their communication to a broad audience about the relative safety of vaccines, as well as current scientific uncertainty, experts said at the FDLI annual meeting.
Overall Survival Data Collection Can Help Mitigate Bias In Open-Label Studies, US FDA Says
FDA oncology review staff discuss cases studies involving Amgen’s Lumakras and Novartis’ Pluvicto, where there was a perceived loss of equipoise, and how mitigation strategies helped save the latter’s pivotal trial.
Cell/Gene Therapies: Regulatory Strengthening Needed To Ensure Global Confidence
Bolstering regulatory expertise in low- and middle-income countries could help prevent a safety-related disaster that chills enthusiasm for the field, while greater regulatory convergence could help tamp down the proliferation of stem cell clinics, the FDA’s Peter Marks says.
Accelerated Approval: Withdrawing Gene Therapies Could Be Easier Than Small Molecules
The FDA would only withdraw a rare disease gene therapy for “pretty clear” reasons, such as when there is minimal benefit with extensive side effects. The one-and-done nature of administration also makes withdrawal easier, CBER Director Peter Marks says.
Project 5 In 5: US FDA Oncology Office Seeks Pragmatic Trial Proposals From Clinicians, Patients
Industry has been slow to embrace the idea of pragmatic clinical trials with streamlined data collection, so the Oncology Center of Excellence now is turning to the broader cancer community for research proposals.