Latest From Grace Moser
FDA Opioid Review Adds Another Push For Advisory Committee Overhaul
External report on the US FDA’s response to the opioid epidemic includes detailed recommendations for enhancements to the advisory committee review process. That dovetails with the agency’s ongoing look at how best to use the expert panels.
US FDA Food Safety Overhaul Will Have Ripple Effects For Drug Inspections
A restructuring of FDA’s food safety operations includes changes to the agency-wide office that handles all inspections, including those of drug manufacturers. It’s another shift in the delicate balancing of centralized management of ORA with the specific needs and priorities of the different centers.
US FDA Food Safety Overhaul Will Have Ripple Effects For Drug Inspections
A restructuring of FDA’s food safety operations includes changes to the agency-wide office that handles all inspections, including those of drug manufacturers. It’s another shift in the delicate balancing of centralized management of ORA with the specific needs and priorities of the different centers.
Advanced Manufacturing May Require US FDA To Think Differently About Guidance
National Academies report argues that technologies cannot only be evaluated in the context of specific products, and FDA guidance should become both ‘more fluid and targeted.’
Advanced Manufacturing May Require US FDA To Think Differently About Guidance
National Academies report argues that technologies cannot only be evaluated in the context of specific products, and FDA guidance should become both ‘more fluid and targeted.’
US FDA ‘Project Post COVIDity’ Will Track Infection Impact On Cancer Patients Using Real-World Data
Oncology Center of Excellence program will use the Evidence Accelerator to examine COVID’s impact on treatment initiation, regimen selection and therapeutic utilization, potential adverse sequalae, and outcomes.