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

Clinical Trials: US Diversity Action Plans Could Benefit From EQBMED Pilot Program

The Equitable Breakthroughs in Medicine Development initiative, funded with a PhRMA grant, provides sites in historically under-represented communities with support to conduct clinical research. In an interview, EQBMED’s Tesheia Johnson Harris talks about the local sites selected, therapeutic areas for research, and learnings to date.

US FDA Takes Lilly’s Mounjaro, Zepbound Off Shortage List But Gives Compounding Grace Period

Compounding pharmacies have 60 days, and outsourcing facilities 90 days, to transition patients to branded products.

Planned Departure Of FDA Principal Deputy Commissioner Could Leave Leadership Vacuum

Namandje Bumpus' departure means there is no obvious, internal candidate to serve as acting commissioner when President-elect Donald Trump takes office in January and the Senate works to confirm a new leader.

US FDA Principal Deputy Commissioner Bumpus Leaving At Year’s End, Creating Leadership Void

Namandje Bumpus' departure means there is no obvious, internal candidate to serve as acting commissioner when President-elect Donald Trump takes office in January and the Senate works to confirm a new leader.

US FDA Principal Deputy Commissioner Bumpus Leaving At Year’s End, Creating Leadership Void

Namandje Bumpus' departure means there is no obvious, internal candidate to serve as acting commissioner when President-elect Donald Trump takes office in January and the Senate works to confirm a new leader.

Postmarket Studies A Good Fit For Pragmatic And Decentralized Elements

Incorporating pragmatic and decentralized approaches into postapproval studies presents less risk for data collection and reliability than in the premarket setting, an expert panel said at a Friends of Cancer Research meeting.