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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

CDER Planning Guidances On Single-Trial Approvals, Real-World Evidence

US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.

Guidance Documents Drug Approval Standards

Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA

AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.

Review Pathway Post Market Regulation & Studies

2020 In Review: US FDA New Drug Office’s COVID-19 Response Aided By Reorganization

Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.

Pink Sheet Perspectives FDA

Postmarketing Safety Gets Closer Focus In Latest US FDA Drugs Center Reorganization

Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.

Drug Safety Generic Drugs

‘Frontline’ Essential Workers, Persons 75 Years And Older Prioritized For Second Phase Of COVID Vaccination

Essential workers who cannot work remotely and have high levels of interaction with the public, and individuals ≥75 years old, should get vaccinated ahead of those 65-74 years old and those with comorbid conditions, CDC Advisory Committee on Immunization Practices recommends.

Vaccines Coronavirus COVID-19

The Pfizer Effect: Moderna Tries To Escape Big Pharma’s Shadow At US FDA Vaccines Panel

Sponsor and agency sought to proactively address questions about the potential for anaphylactic reactions with the COVID-19 vaccine given the early real-world experience with Pfizer’s inoculation, which is also uses mRNA technology.

Advisory Committees Coronavirus COVID-19
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