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
In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.
In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.
Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.
Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.
However, the agency updated warnings on myocarditis risk and mitigation for the gene therapy, including more specific information about its severity and timeframe for occurrence in Duchenne muscular dystrophy patients.
A webpage for PharmaTher’s ketamine product lacked risk information and made misleading claims about the approved indication, the FDA said in a rare ad/promo violation letter to an ANDA holder.