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Sue Sutter

Senior Editor

Washington, DC
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 Trial Diversity Action Plans Will Take 100 Hours To Prepare, US FDA Predicts

The agency’s Center for Drug Evaluation and Research expects to receive 200 plans annually, with 40 plans expected to go to the biologics center.

Clinical Trials Diversity & Inclusion

Chevron’s Fall Strengthens Industry’s Hand In Disagreements With US FDA, But May Create Delays

Firms can be more forceful in disputes with FDA now that Supreme Court has eliminated Chevron deference. Questions around whether an evidentiary standard has been met may be ripe for challenge, legal experts said, but they also caution that sponsors will face more uncertainty.

Legal Issues FDA

Chevron’s Fall Strengthens Industry’s Hand In Disagreements With US FDA, But May Spur Delays

Firms can be more forceful in disputes with FDA now that Supreme Court has eliminated Chevron deference. Questions around whether an evidentiary standard has been met may be ripe for challenge, legal experts said, but they also caution that sponsors will face more uncertainty.

Legal Issues FDA

Chevron’s Fall Strengthens Industry’s Hand In Disagreements With US FDA, But May Spur Delays

Firms can be more forceful in disputes with FDA now that Supreme Court has eliminated Chevron deference. Questions around whether an evidentiary standard has been met may be ripe for challenge, legal experts said, but they also caution that sponsors will face more uncertainty.

Legal Issues Drug Approval Standards

US FDA’s Genetic Metabolic Diseases Adcomm Debuts With Zevra’s Arimoclomol

The new panel’s inaugural 2 August meeting will take up a challenging drug application, currently in its second review cycle, for Niemann-Pick disease type C, an ultra-rare condition without approved therapeutics.

Advisory Committees Rare Diseases

Lilly’s Kisunla Postmarketing Studies Include Maintenance Dosing, But No Safety Trial

Lilly must conduct registry-based and retrospective cohort studies, similar to those required for Eisai/Biogen’s Leqembi, to assess the risks of ARIA and intracerebral hemorrhage with donanemab, but there is no additional requirement for a safety-focused clinical trial.

Approvals Clinical Trials
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