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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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Eteplirsen Revisited? FDA Panel To Weigh Protocol Changes For Two Sarepta Drugs

US agency’s advisory committees will consider whether ongoing trial of exon 45- and 53-skipping compounds for Duchenne muscular dystrophy should allow use of in-dwelling ports to aid infusion.

Advisory Committees Pediatrics

Samsung’s Renflexis: Second US Biosimilar To Janssen’s Remicade, With A Few Firsts

Infliximab-abda gains FDA licensure without having faced an advisory committee review; under current case law, launch could come as early as mid-October.

Biosimilars Approvals

Opioids: FDA Eyes Better Prescriber Education, But Academics Urge Promotion Crackdown

US agency is convening two-day workshop on federal efforts to support healthcare provider education about pain management and safe use of the drugs; two University of Washington researchers say agency needs to exercise stricter oversight of opioid marketing and promotion.

Drug Safety Risk Management

Cancer Drug Trials Could Benefit From ‘Rational’ Eligibility Criteria

US FDA drug reviewers argue that enrolling more heterogeneous patient populations could result in fewer postmarketing requirements and earlier satisfaction of pediatric study obligations.

Clinical Trials Research and Development Strategies

Biosimilar Sponsors Took Delivery Device Shortcuts For Erelzi, Amjevita

Sandoz’s and Amgen’s biosimilars employ autoinjectors that are currently used with the sponsors’ novel biologic products, allowing them to avoid additional human factors study testing of the delivery devices.

Drug Review Profile Biosimilars

Sandoz’s Erelzi: Biosimilar Pediatric Labeling Strayed From Enbrel

Drug Review Profile of TNF-inhibitor etanercept-szzs examines how US FDA navigated its way around ‘inaccurate’ pediatric psoriasis labeling for the reference product, Amgen’s Enbrel, to reflect current state of the knowledge on the biosimilar’s labeling, albeit only temporarily.

Drug Review Profile Biosimilars
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