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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

Cancer Drug Dose Optimization Benefits Include Better Pivotal Trial Retention, Fewer Clinical Holds

US FDA is asking oncology sponsors for randomized studies comparing at least two doses early in development; despite concerns about delaying approval, FDA and industry reps say approach will increase success of registrational trials and reduce likelihood of market withdrawal due to toxicity.

Clinical Trials ImmunoOncology

US FDA’s Drugs Center Wins Round One In Makena Dispute With Covis On Document Production

Company is not entitled to CDER's unredacted materials or predecisional drafts and emails on the proposed withdrawal of accelerated approval. However, presiding officer Celia Witten sets a 24 January deadline for CDER’s document production and requests the center re-examine what materials from a medical policy council meeting can be released.

Review Pathway Post Market Regulation & Studies

Cancer Drug Endpoints: ctDNA Promising But Presents Many Challenges, Experts Say

To validate change in circulating tumor DNA as an early endpoint predictive of longer-term outcomes, academia, industry and regulators must harmonize data collection for trials in early-stage disease, a Friends of Cancer Research white paper states.

Clinical Trials Review Pathway

US FDA Tags Moderna COVID-19 Vaccine With Higher Myocarditis Risk Than Pfizer/BioNTech

In expanding authorization of booster doses for both mRNA vaccines, the agency updated Moderna’s fact sheet to state the vaccine appears to pose a higher risk of myocarditis/pericarditis in males under age 40 years after the second dose, although data are ‘not yet dispositive.’

Coronavirus COVID-19 Vaccines

US FDA Cancels Panel Review Of Two ‘Delinquent’ Cancer Drug Accelerated Approvals

Confirmatory trial for Secura Bio’s Farydak has been delayed for several years, while the study for Acrotech’s Marqibo was terminated early; a 2 December advisory committee meeting to consider the drugs’ fate was cancelled, which could mean the sponsors reached new study agreements with the FDA or plan to withdraw the drugs.

Advisory Committees Post Market Regulation & Studies

Pfizer’s Comirnaty: Emerging Myocarditis Signal Drew Flurry Of Attention During Compressed BLA Review

Multiple offices within CBER worked to get a handle on the myocarditis issue in the midst of a three-month review of the COVID vaccine, with US FDA staff undertaking a quantitative benefit-risk assessment and negotiating with Pfizer on postmarket safety studies.

Drug Review Profile Vaccines
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