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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

CellTrans’ Donislecel Gets US FDA Panel Nod For Small Group Of Type 1 Diabetics

Benefits of independence from exogenous insulin outweighed the risks from long-term immunosuppression necessary with the allogeneic pancreatic islet cellular therapy, majority of panelists said, but they urged the FDA to limit the indication to a very small subpopulation of patients.

Advisory Committees Drug Review

US FDA Oncology Center Wants Trial Datasets Flagged As Remote Or In-Person Assessments

Agency wants to use pandemic-interrupted clinical trials to gauge how decentralized approaches impacted study integrity and to inform prospective use of such designs post-COVID.

Clinical Trials Coronavirus COVID-19

CellTrans’ Donislecel: Insulin Independence Data May Offer Path To Market In Type 1 Diabetes

Proportion of subjects with freedom from exogenous insulin ‘might support the efficacy’ of the allogeneic islet cellular therapy, US FDA says after concluding that issues in two studies limit interpretability of primary analyses based on severe hypoglycemic events and HbA1c levels. An advisory committee will weigh clinical efficacy, safety and product characterization issues.

Advisory Committees Regenerative Medicine

COVID-19 Vaccine Authorization In Adolescents Would Raise Questions Around Routine Immunizations

US FDA not planning an advisory committee for Pfizer/BioNTech’s request for authorization in 12-15-year olds at this time, but CDC’s ACIP is likely to weigh how to balance timing of COVID vaccination with administration of other immunizations generally recommended for adolescents.

Coronavirus COVID-19 Vaccines

JAK-Inhibitor Review Delays Spur Talk Of US FDA Panel Meeting On Class Safety

After Pfizer saw increased risks in a surveillance study of Xeljanz, three other products have also seen their user fee dates pushed back; if FDA were to convene an expert panel, it could lead to more consistent labeling across the class, as requested in a recent citizen petition.

Drug Review Drug Safety

Early ‘Scattershot’ Approach To COVID-19 Therapeutic Research Generated Little Actionable Data

US FDA and NIH leaders cite lack of early clinical trial coordination as a weakness in the pandemic response that led to use of compounds that were potentially harmful and, even today, still not proven to be effective.

Clinical Trials Coronavirus COVID-19
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