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
Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.
The Risk Evaluation and Mitigation Strategy hindered access and burdened the health care system even though it was never fully implemented or enforced. The FDA still recommends prescribers monitor patients’ absolute neutrophil count to prevent severe neutropenia.
Foster, an advisor to the HHS Assistant Secretary for Preparedness and Response during the COVID-19 pandemic and counsel to the Senate HELP Committee, also served in various legal roles at small biotech companies. He replaces agency veteran Mark Raza.
A declaratory order removing semaglutide from the FDA shortages list duplicates much of the language in a December decision still in litigation that declared Eli Lilly’s tirzepatide products Mounjaro and Zepbound were no longer in shortage.
Reporter and editors from the Pink Sheet, Medtech Insight and HBW Insight consider the impact of the layoffs at the FDA on its drug, device and consumer products divisions, as well as the so-far limited public reaction from industry.
Foster, an advisor to the HHS Assistant Secretary for Preparedness and Response during the COVID-19 pandemic and counsel to the Senate HELP Committee, also served in various legal roles at small biotech companies. He replaces agency veteran Mark Raza.