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The US FDA aims to prevent poor quality or incomplete responses to Form 483 inspection observations with a new draft guidance that describes the structure and content for concise, factual and effective corrective action responses.
Context of use, human biological relevance, technical characterization and fitness for purpose are the key elements in validating novel methods to replace animal testing, the FDA said in a new draft guidance.
The agency is conducting further investigation of reports of altered skin sensation that occurred more frequently with the 7.2 mg semaglutide dose than with lower doses of the GLP-1 inhibitor.
Context of use, human biological relevance, technical characterization and fitness for purpose are the key elements in validating novel methods to replace animal testing, the FDA said in a new draft guidance.
Plaintiffs are likely to succeed on the merits of claims that reconstitution of the Advisory Committee on Immunization Practices violated the Federal Advisory Committee Act and the CDC improperly bypassed ACIP in adopting a new childhood vaccine schedule, a Boston judge said.
An HHS administrative law judge will preside at the formal evidentiary hearing, which stems from a 2019 complete response letter that was followed by administrative and legal appeals, even though Vanda said it would only accept the FDA commissioner as presiding officer.