HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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 Office Of New Drugs Has New Deputy Director In Thanh Hai

The move means Hylton Joffe can focus exclusively on his role as director of the Office of Rare Diseases.

United States FDA

Virtual US FDA Advisory Committees May Have One Silver Lining: Available Experts

The agency historically has had challenges recruiting experts for its advisory committees. With most everyone working from home during COVID-19, that task was just made easier, 3D Communications’ Jim DiBiasi says.

Advisory Committees Drug Review

COVID-19 Vaccine Manufacturing: CBER Seeking Capacity Through Collaboration

While a vaccine candidate is still months away, US FDA is already working to identify manufacturing capacity, CBER’s Peter Marks says in an interview.

Coronavirus COVID-19 Manufacturing

US FDA Preparing For Less-Than-Ideal COVID-19 Vaccine Studies

The best vaccine development program would include robust clinical trials, CBER Director Marks says in an interview, but that depends on what’s happening with viral transmission on the ground.

Coronavirus COVID-19 Vaccines

Gene Therapy May Pack US FDA’s Calendar This Fall; CBER Staffs Up

Just as COVID-19 work begins to wane, CBER’s Peter Marks expects an influx of gene therapy work as sponsors attempt to salvage clinical trials.

Gene Therapy Coronavirus COVID-19

US FDA Coronavirus Response Features Three-Step Triage Process For Inquiries

Office of New Drugs Director Peter Stein outlines how his reviewers are prioritizing COVID-19 work, and how he is reallocating resources to the pandemic response.

Coronavirus COVID-19 Drug Review
See All