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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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Latest From Sue Sutter

Biosimilars Statistical Guidance Reflects Early Development Approach

US FDA's long-awaited draft guidance on statistical approaches for analytical similarity testing appears to echo what agency has been telling biosimilar product sponsors in private about ranking and testing reference product attributes according to criticality.

Biosimilars Research & Development

US FDA's Benefit/Risk Framework Gets High Marks But Could Be Improved

Agency summaries contained in reviews of novel drugs and biologics are useful and informative but difficult to find, and their use should be expanded to other types of applications, industry sponsors and other external stakeholders say.

Drug Review Drug Safety

Butrans Pediatric Labeling Draws Mixed Views At US FDA Panel

Opponents say including data from a small pediatric trial of Purdue's buprenorphine patch could give the impression the study was more robust than it actually was, while supporters say labeling should reflect any available data that can inform pediatric prescribing.

Advisory Committees Pediatrics

Alzheimer's Guidance Coming From US FDA, Part Of Broader OND Reform

'Believe it or not, we don't have as many disease-specific guidances as you would suspect on the new drug side,' Commissioner Gottlieb says.

Clinical Trials Research & Development

US FDA's Centralized Patient Affairs Office Aims For No Disruption

New office will develop agency-wide patient engagement policy and serve as entry point for patient groups new to FDA, but will not interfere with existing relationships between advocates and the drugs and biologics centers, FDA Commissioner Gottlieb says.

FDA Drug Approval Standards

OxyContin Repeat? US FDA Seeks To Avoid Fallout Over Butrans Pediatric Data

Advisory committees will discuss whether data from a 41-patient study should be added to Pediatric Use section of labeling for Purdue's buprenorphine product; agency's decision to convene expert panel even though a pediatric indication is not being considered grew out of criticism generated by approval of OxyContin for adolescents.

Advisory Committees Pediatrics
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