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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

Moving Beyond Aduhelm: Cell/Gene Therapy May Be ‘Poster Child’ For What Comes Next

Former FDA principal deputy commissioner Amy Abernethy says cell and gene therapy is an area primed for improved ‘parallel conversation’ between FDA and CMS on data requirements.

Medicare Gene Therapy

US FDA Project Protect Oncology Safety Program In Broad Use After Quiet Launch

Project Protect is the Oncology Center of Excellence’s latest program to support cancer drug development; the safety signal tool has been used to support 44 drug applications.

Drug Safety Cancer

US FDA ‘Actively Working’ To Fill Vaccine Leadership Positions Ahead Of Next Round Of COVID Reviews

As decisions on additional boosters and childhood inoculations loom, CBER Director Peter Marks is still heading the vaccines division on an acting basis since the departures of Marion Gruber and Philip Krause last year. Who might succeed them?

Vaccines Leadership

CBER Sees Steady Increase In Emergency IND Requests – And A Big COVID Spike In FY 2020

Outside the pandemic, sponsor INDs for investigational cell and gene therapies appear to be driving much of the increase, and the surging growth continues to cause workload challenges for the US FDA.

Gene Therapy Drug Review

Unger Unplugged: FDA Needs Accelerated Approval To ‘Take More Chances’ – But Also A Clear Path To Withdrawal

Former cardiology review office director Ellis Unger suggests 70% chance for AA drugs to confirm benefit is an appropriate benchmark, but agency comes nowhere close to withdrawing the remaining 30%.

Drug Approval Standards Review Pathway

China-Only Studies Are ‘Problematic,’ US FDA’s Pazdur Says Ahead Of Lilly/Innovent PD-1 Inhibitor Review

February advisory committee for sintilimab expected to address three main questions about applications relying on single-country data.

Cancer Clinical Trials
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