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Sue Sutter

Senior Editor

Washington, D.C.
Sue is a senior editor with Pink Sheet, where she writes primarily about drug, biologic and biosimilar regulation, FDA advisory committees and product approvals.  She has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the umbrella of Informa Business Information, including Pink Sheet, “The Pink Sheet” DAILY, “The Tan 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.
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Latest From Sue Sutter

Pediatric Cancer Studies: US FDA Promises Flexible Approach On Requirements

FDA says it will not be 'held hostage' by its list of molecular targets, but patient advocates worry agency will be deterred from requiring assessments for targets not on the list, while industry worries about being surprised by demands for pediatric data.

Clinical Trials Pediatrics

Opioid-Sparing Claims Should Meet High Bar, US FDA Panel Says

At meeting on Pacira's Exparel, advisory committee members warn against rushing to adopt products purported to reduce opioid consumption absent long-term longitudinal data showing beneficial public health impacts and clinical data linking reduced opioid use to functional outcomes or other clinical benefit.

Advisory Committees Drug Approval Standards

Seeking A Meeting? CDER Wants Patient Advocacy Groups To Go Online

Web portal makes it easier for non-industry stakeholders to request meetings on development and safety matters but might sow confusion for some patient groups, particularly when it comes to externally led patient-focused drug development meetings.

FDA Drug Approval Standards

Pacira's Exparel: US FDA Panel Narrowly Rejects Nerve Block Claim

Inconsistent efficacy data and safety concerns about falls and systemic toxicity lead to advisory committee vote against a labeling expansion for the local anesthetic; Pacira's proposed revisions to the drug's existing infiltration claim also meet some resistance.

Advisory Committees Drug Review

Pacira's Exparel Faces Efficacy Questions On Nerve Block Indication

US FDA advisory committee to weigh whether efficacy data support an expanded label for the local anesthetic; despite Pacira's completion of two new studies following a complete response letter, FDA continues to harbor concerns about adequacy of the data to support a broad nerve block claim.

Advisory Committees Drug Review

Erelzi's Disappearing Indications: Biosimilar Loses Two Of Enbrel's Labeling Claims

Sandoz's request that US FDA remove psoriatic arthritis and plaque psoriasis indications from biosimilar's approved labeling appears aimed at defending against patent infringement claims brought by Amgen, legal experts say.

Biosimilars Intellectual Property
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