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
The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.
At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.
Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.
A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.