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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.
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Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions

Long-planned OND 'modernization' to better match workflow, allow more time with stakeholders includes proposed restructuring that would boost number of offices overseeing review operations (adding four for a total of nine) and drug review divisions (adding 11 for a total of 30).

Drug Review Leadership

Division Directors Wanted: Will US FDA Look Outside For New Leaders?

Revamped Office of New Drugs will create many new opportunities for FDA to promote from within. But FDA may also need to recruit from outside for candidates to take on management roles. While that is not typical, there are successful examples.

FDA Leadership

US Office Of New Drugs Revamp Taking Shape: More Review Divisions Coming, But Who Will Lead Them?

FDA reaches final stages of reorganization that will better distribute an ever-increasing review workload; recent high-level departures will make filling even more management slots difficult.

Drug Review FDA

Alkermes Refuse-To-File Reversal: Is It Really Good News For Anyone?

US FDA’s decision to 'un-refuse' ALKS 5461 was made within same review office that was caught up in the Sarepta controversy – albeit in a different division. What does the RTF reversal mean for Alkermes and for the agency?
Drug Review Drug Approval Standards

'Right-To-Try' Has US FDA Support: Scaled-Back House Bill Retains Agency Oversight

Commissioner Gottlieb’s recent remarks on pending federal 'Right-to-Try' legislation were his most positive to date; he pushed back on earlier versions that would have removed FDA from process. 
Legislation Policy

Grading Gottlieb: A Podcast Report Card

Prevision policy experts discuss where US FDA commissioner has been most effective, room for improvement, and what would make for a second successful year.
Leadership FDA
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