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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

US FDA Expands Drug Development Tool Qualification Program With ISTAND Pilot

ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.

Clinical Trials Drug Approval Standards

Transparency On COVID Vaccine Clinical Holds Needed, Sharfstein Says; US FDA Advisory Cmtes Offer Venue

Former acting Commissioner Josh Sharfstein argues that while agency officials have done a commendable job in overall communication on COVID vaccine development, more information is needed on the clinical holds.

Advisory Committees Clinical Trials

‘The Gruber Moment’: How CBER Got The Answers It Wanted On COVID Vaccine Guidance

As US FDA recovers from aducanumab and looks towards an advisory committee on Pfizer’s COVID vaccine, it’s worth reflecting on how Office of Vaccine Research & Review Director Marion Gruber created positive turning points for the agency during a general discussion of vaccine approval standards at the VRBPAC.

Advisory Committees Leadership

Time For Independent US FDA? COVID Political Pressure Reignites Debate

The political spotlight on the FDA during the coronavirus pandemic has renewed long-standing debate as to whether it should be made an independent, Cabinet-level federal agency and freed from direct HHS oversight.

US States North America

Accelerated Approval Under Review By US FDA: Completing Confirmatory Trials A Focus

Top officials want confirmatory trials to finish in a ‘reasonable amount of time’ and worry that ‘if 100% of them were able to confirm, then the bar’s too high.’

Review Pathway Drug Approval Standards

Time For Independent US FDA? COVID-19 Political Pressure Reignites Debate

The political spotlight on FDA during the COVID-19 pandemic has renewed the long-standing debate as to whether it should be made an independent, Cabinet-level federal agency and freed from direct HHS oversight.

FDA Policy
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