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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.
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Clinical Trials: US FDA Should Frame Risk-Based Monitoring As Best Practice, ACRO Says

Recent Q&A draft guidance is aimed at assisting sponsors in planning and conducting risk-based approaches to monitoring, but ACRO’s Doug Peddicord says agency needs to take a more straightforward, proactive approach to encouraging the move away from 100% source data verification.

Clinical Trials Digital Health

‘Project Facilitate’: US FDA Plans May Meeting On Expanded Access Call Center

Oncology Center of Excellence pilot program is intended to make the single patient IND process easier to navigate and more efficient; regulatory project managers will help walk providers through the process and provide contact information for drug companies and institutional review boards.

Clinical Trials Review Pathway

Cancer Trials: US FDA Guidances Aim To Expand Eligibility Criteria And Better Inform Labeling

Draft guidances reflect the agency’s thinking on when patients with HIV/hepatitis infection, brain metastasis, organ dysfunction or prior malignancies, as well as pediatric patients, should be enrolled in cancer trials; FDA also finalizes recommendations on adolescent enrollment in adult studies of oncology drugs.

Clinical Trials Regulation

Cipla, Piramal Launch Sensipar Generics Amid Growing Antitrust Challenges to Amgen/Teva Settlement

Amgen seeks a preliminary injunction to halt US sales by Cipla and says it will take steps to stop Piramal’s sales; in its antitrust lawsuit, Cipla alleges Amgen paid to license Teva products under the companies’ patent settlement, which resulted in Teva pulling its generic off the market shortly after launch.


Generic Drugs Launches

Sanofi Gets A Helping Hand From US FDA At Dengvaxia Review

After split verdicts on efficacy and safety for Sanofi’s proposed population for the dengue vaccine, FDA added two new questions limited to pediatric use, which drew strong advisory committee support.

Advisory Committees Vaccines

Sanofi’s Dengvaxia: US FDA Panel Finds Pediatric Use More Acceptable Than Broader Target Population

Even a more limited label for the dengue vaccine may not be enough to overcome the lack of a readily available and reliable point-of-care diagnostic for screening potential vaccine recipients for previous dengue infection.

Advisory Committees Vaccines
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