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

Tipping Point: Tariffs Create Uncertainty, Risk Long-Term Price Increases, Shortages

President Trump’s 10% tariff on active pharmaceutical ingredients and finished dosage forms could push some generic drug makers to exit therapeutic categories if they cannot absorb the new costs, which could lead to shortages.

‘Fear And Anxiety’ As Rare Disease Community Confronts US Government Actions

The sudden halt to grants and health agency communications is causing stress for the rare disease advocacy community, speakers said at a recent rare disease symposium.

Pink Sheet Podcast: Kennedy’s Assurances To Gain HHS Nod, US FDA Coms Freeze Continues Thawing

Pink Sheet reporter and editors discuss what pushed a crucial Senate Finance Committee swing vote to support Robert F. Kennedy Jr. as HHS Secretary and the FDA slowly expanding its communications with the public amid the Trump Administration freeze.

Rare Disease Community Stressed By US Funding Threats, Communications Freeze

There has been “a lot of fear and anxiety” resulting from the Trump Administration’s early actions aimed at freezing grants and FDA communications, NORD’s Pamela Gavin says.

FDA Communications In Flux As HHS Assesses Mission-Critical Activities

As the US FDA determines what media inquiries it can respond to, HHS is deciding whether planned actions or meetings can move forward, depending on whether they are deemed mission-critical.

Vertex’s Pain Drug Journavx Breaks Through US FDA Communications Freeze

The FDA announcement of the novel, non-opioid drug’s approval highlights public health implications, which probably helped it clear the communications freeze. Recent website updates and forthcoming Federal Register notices suggest the freeze could be thawing slowly.