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Kate Rawson

Kate Rawson is a Contributing Editor at Prevision Policy. She was a Senior Editor at The RPM Report and reporter and editor at The Pink Sheet where she covered drug regulation and reimbursement issues. During her ten-year tenure at FDC Reports, she helped launch The Pink Sheet DAILY, and also served as Managing Editor of The Rose Sheet, which covers regulatory and business news of the cosmetics industry.

Latest From Kate Rawson

COVID-19 Vaccine ‘Booster’ Or Simply A Third Dose? US FDA’s Marks Starts To Reframe The Issue

It’s a classic example of an internal dispute between an FDA review team and agency leadership playing out at an advisory committee forum, except with the highest possible stakes.

Coronavirus COVID-19 Vaccines

Pazdur To Oncology Drug Developers: Step Back, Slow Down – And Find The Right Dose

FDA’s “Project Optimus” draft guidance on dose optimization is in the works. Until then, randomized dosing studies need to be an IND-level conversation.

Cancer Clinical Trials

US FDA Advisory Committee Reboot (Part III): Asking The Right Questions

Rethinking the voting and discussion questions to advisory committees may be one way to ensure FDA gets the advice it needs.

Advisory Committees Drug Review

US FDA Advisory Committee Reboot (Part II): The Right Balance For Conflicts Of Interest

After back-and-forth tinkering with CoI restrictions, CDER is still finding it challenging to seat the right experts. Maybe more realistic guidelines are needed.

Advisory Committees Drug Review

US FDA Advisory Committee Reboot (Part I): Open Public Meeting A Place To Start?

CDER Director Patrizia Cavazzoni raised eyebrows when she stated an intent to remove the ‘emotional overtone’ of committee meetings. The open public hearing may be a place to start.

Advisory Committees Drug Review

Aduhelm’s ‘Complex’ Circumstances Drove Extensive In-House Advice Process Before Accelerated Approval, Cavazzoni Says

Accelerated approval was considered as option in response to the negative advisory committee vote, but it was not a ‘default,’ CDER officials say. ‘It fit like a glove.’

Approvals Review Pathway
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