Sue primarily covers US drug, biologic, vaccine and biosimilar regulation and policy across therapeutic areas, with an emphasis on advisory committee reviews, FDA approvals and use of expedited review pathways. Sue has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the Citeline umbrella, including Pink 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. She grew up in South Jersey and spends her free time watching youth sports, gardening, walking and hiking, although she'd rather be at the beach.
Latest from Sue Sutter
ARS Pharmaceutical and Altor BioScience received second untitled letters for identical or similar promotional claims that the agency flagged as violative in its September enforcement blitz.
The agency veteran brings extensive generic and new drug experience to Acting CDER Director Tracy Beth Høeg’s leadership team and fills a position that has been vacant since Douglas Throckmorton retired a year ago.
However, their recommendation, coupled with those of the Commissioner’s National Priority Voucher Review Council, likely will be a source of pressure on scientific reviewers and the division or office directors who are the signatory authorities on applications.
Pink Sheet editors discuss the average speed of FDA novel drug application reviews in 2025 and consider whether staffing departures and general upheaval throughout the year will impact times in 2026.
Sponsors now must specify domestic manufacturing facilities and bioresearch monitoring study sites at least 60 days before the complete application is submitted, which appears intended to ensure inspections keep pace with the compressed review timelines.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.