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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

BsUFA III: Industry Eyes Streamlined Review Of New Indications, Phased Review Process

Janssen and Amgen suggest user fee agreement changes aimed at speeding review process for some biosimilar applications and supplements in comments to US FDA on biologic product competition and innovation, while Merck presses agency to clarify its current view on cross-product labeling.

Biosimilars Legislation

US FDA Panel Will Reckon With Need For Diabetes Drug CV Risk Assessments

Cardiovascular and non-CV safety findings from completed outcomes trials to date for eight drugs, as well as the relative paucity of preapproval CV data available for anti-diabetic agents prior to a December 2008 guidance that mandated dedicated risk assessments, may inform advisory committee's view on continuing need for large safety trials.


Advisory Committees Drug Approval Standards

Keeping Track: Pfizer’s Talzenna Ensures Record Year For Novel US Approvals; Novartis Submits SMA Gene Therapy

The latest drug development news and highlights from our FDA Performance Tracker.

US FDA Performance Tracker Drug Review

US Drug Pricing: CMS Seeks Feedback On DTC Ad Enforcement Mechanism, Disclosure Statement

Centers for Medicare and Medicaid Services asks whether private actions under Lanham Act are sufficient for enforcement, or whether participation in federal health programs should be conditioned on including drug list prices in direct-to-consumer TV commercials; comment deadline on controversial proposed rule is Dec. 17.

Pricing Debate Advertising, Marketing & Sales

Shire’s Motegrity: US FDA Panel Nod On CV Safety Comes With Concern About Neuropsych Events

In unanimously endorsing prucalopride for chronic idiopathic constipation, advisory committee seems reassured by extensive data on 5-HT4 agonist’s cardiovascular safety, but some members called for an epidemiological study to assess possible suicidality signal.


Advisory Committees Drug Review

Real-World Data: Precertification Could Aid Use For Regulatory Decisions

Voluntary precertification process could help ensure the quality and integrity of databases from which real-world evidence is derived, but the program could be a cost burden for data curators and accreditation criteria would need to be developed, experts said at a recent Duke-Margolis Center meeting.

Drug Approval Standards Post Market Regulation & Studies
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