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
Stealth has until March 2026 to begin enrolling its confirmatory trial for its Barth syndrome drug elamipretide, marking a rare instance where a novel drug received accelerated approval even though the required postmarketing study was not underway.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The Advisory Committee on Immunization Practices recommended against continued use of Merck’s measles, mumps, rubella and varicella combination vaccine in very young children, but voted to retain coverage for the same use in the Vaccines for Children program.
The Give Kids A Chance Act would renew the PRV program that began to sunset in December 2024. The House Energy and Commerce Committee advanced the pediatric- and rare disease-focused package, but also included generic drug transparency provisions.
Recently released CRLs for unapproved products contain recommendations for new studies, including design element details and advice to consider different submission pathways.
Just eight of the 68 warning letters posted by the FDA to date went to innovator companies, but GLP-1 agonists still were a focus.