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 FDA announcement of the novel, non-opioid drug’s approval highlights public health implications, which probably helped it clear the communication’s freeze. Recent website updates and forthcoming Federal Register notices suggest the freeze could be thawing slowly.
Pink Sheet reporter and editors discuss Sara Brenner’s introduction as acting FDA commissioner, Robert F. Kennedy Jr.’s confirmation hearings, the Trump Administration’s plans to end telework, and postponed meetings and other issues related to the communications freeze and travel ban.
Lilly’s complaint to the National Advertising Division, a self-regulatory forum for industry, about an Oregon clinic’s claims expands the battlefront against widespread compounding of GLP-1 products for weight loss and diabetes treatment.
The inspector general said the council should be more involved in specific approval decisions when there is internal disagreement, but FDA said that would preclude some individuals from adjudicating a subsequent withdrawal proceeding.
A Trump Administration communications freeze and travel ban may be complicating efforts to convene FDA advisory committees. A 5 February meeting on postmarketing requirements for extended-release/long-acting opioids was postponed, while a 24 February meeting on a Novartis rare disease drug was cancelled.
The FDA's interim leadership takes shape, but the sense of transition chaos still lingers.