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Grace Moser

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.

Drug Approval Standards Advisory Committees

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.

Manufacturing Regulation

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.

Manufacturing Regulation

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.’

FDA Guidance Documents

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.’

Manufacturing Guidance Documents

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.

Cancer Coronavirus COVID-19
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