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Sue Sutter

Senior Editor

Washington, D.C.
Sue is a senior editor with Pink Sheet, where she writes primarily about drug, biologic and biosimilar regulation, FDA advisory committees and product approvals.  She has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the umbrella of Informa Business Information, including Pink Sheet, “The Pink Sheet” DAILY, “The Tan Sheet” and Scrip.  Previously she worked as an editor for Mealey’s Litigation Reports (now part of Lexis-Nexis), writing about asbestos, toxic tort and fen-phen litigation.

Latest From Sue Sutter

Walensky Defends Decision To Go Against Advisors On Pfizer COVID Booster Recommendation

‘If I had been in the room, I would have voted yes,’ CDC director says of ACIP. ‘This was a scientific close call. ... And that was how my recommendations came out after listening to all of their scientific deliberations.’

Coronavirus COVID-19 Vaccines

One Down, Two To Go: Pfizer/BioNTech Booster Decision Creates Pressure For More Extra Shot Authorizations

Inequity created by limiting the mRNA vaccine’s third dose to only those individuals who received a primary series of the same vaccine, as well as resulting operational complexities, warrant consideration of a mix-and-match approach with Moderna and J&J products, CDC advisors say; however, FDA appears most focused on vetting manufacturer-specific data on homologous boosting.

Advisory Committees Coronavirus COVID-19

Pfizer COVID Booster Recommendations From CDC Panel Narrower Than FDA's EUA

Advisory Committee on Immunization Practices fails to pass an interim recommendation endorsing third dose of vaccine in health care workers and others at risk of occupational or institutional exposure, with panelists raising concern that the target population was overly broad.

Coronavirus COVID-19 Vaccines

Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors

Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’

Review Pathway Clinical Trials

US FDA Panel Rejects Pfizer's Broad COVID Booster Plan But Backs Narrower Authorization For Third Vaccine Shot

Advisory committee meeting reflected internal tensions among FDA staff on need for boosters and adequacy of the data; mRNA vaccine Comirnaty should be authorized for a third dose in populations at high risk for severe disease or exposure, panel says after overwhelmingly rejecting Pfizer's bid for booster approval in the 16-and-older population. 

Advisory Committees Coronavirus COVID-19

Real-World Evidence Will Take Center Stage At US FDA Advisory Committee On COVID Boosters

If regulators agree with Pfizers conclusions – and briefing documents suggest thats a big if – about real-world studies showing Comirnatys effectiveness waning over time, thereby justifying the need for a booster dose, it could be part of a historical moment for FDA’s use of RWE.

Advisory Committees Coronavirus COVID-19
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