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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

COVID-19 Vaccines: Advisory Committee Picks Apart US FDA Guidance On Efficacy Endpoints

FDA's recommendation that COVID-19 vaccine sponsors conduct two months of median follow-up to support an emergency use authorization may not be long enough, some experts say in what can be viewed as validation for agency's position in battle with White House.

Coronavirus COVID-19 Vaccines

Cast Members In US FDA’s COVID-19 Vaccine Advisory Committee

There are 18 people on the committee that will issue the first recommendations on COVID-19 vaccine development and licensure. Among the experts are a University of Michigan epidemiologist who will serve as acting chairman and seven temporary voting members, two of whom required conflict-of-interest waivers.

Advisory Committees Coronavirus COVID-19

Accelerated Approval Withdrawals Through The Years

Unlike AMAG's Makena, nearly all the products that have seen their accelerated approvals pulled have left the market quietly, our infographic shows.

Drug Approval Standards Review Pathway

Gene Therapy Approval Standards: Available Treatments Influence US FDA’s View On Durability

CBER’s Peter Marks says agency assesses the importance of durability of effect differently for a gene therapy that treats a disease that has no other available therapies versus a condition for which there are multiple approved treatments. Marks’ comments shed more light on the complete response letter for BioMarin’s hemophilia gene therapy Roctavian.

Gene Therapy Regenerative Medicine

Alkermes’ Antipsychotic Clears US FDA Panel Amid Calls For Broader Professional Education Plan

Communication and education on samidorphan’s opioid antagonistic effects should focus on health care providers that prescribe opioids as well as psychiatrists that prescribe olanzapine, advisory committee says in endorsing the safety and efficacy of ALKS 3831.

Advisory Committees Neurology

COVID-19 Should Force ‘Soul Searching’ Over Fragmented US Clinical Trials System, Woodcock Says

Among hundreds of trials underway on potential therapeutics, only about 6% of study arms are expected to yield actionable data because most are nonrandomized, underpowered or underenrolled, Operation Warp Speed’s Janet Woodcock says, renewing her pitch for adoption of master protocols and other approaches to streamline studies and improve efficiency.

Clinical Trials Coronavirus COVID-19
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