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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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Alkermes Advisory Committee Hears More About Refuse-To-File Letter Thanks To Industry Rep

US FDA’s decision to issue refuse-to-file action for Alkermes’ buprenorphine/samidorphan combo for major depressive disorder was one of the review issues brought to light by an unusually active advisory committee industry representative.
Advisory Committees Drug Review

Next Step After 'Right To Try'? Senate Hearing Includes Call To Reopen Orphan Drug Act

Trump Administration’s successful campaign to pass “Right to Try” legislation may be emboldening advocates to push for other policies that will loosen FDA regulatory requirements on rare disease drug development.
Rare Diseases Legislation

US FDA's Streamlined Hiring Pilot Restarts After Delay

Recruiting for “Cures”-funded positions resulted in two hires, then got an HHS review; onboarding time should be reduced significantly, but finding the money to pay the higher salaries remains a challenge under the new process.
Leadership FDA

US FDA Reorg: Centers Will Report Directly To Gottlieb; 'Flattened' Structure Will Make Future Political Transitions Easier

Principal Deputy Commissioner Sherman remains top policy guru and will oversee consolidation of functions currently scattered throughout FDA into the Office of Operations.

Leadership FDA

US FDA Centers Will Report Directly To Gottlieb: 'Flattened' Structure Will Make Future Political Transitions Easier

Principal Deputy Commissioner Sherman remains top policy guru and will oversee consolidation of functions currently scattered throughout FDA into the Office of Operations.

Leadership FDA

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
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