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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

Antibiotic Incentives: Pfizer’s Read Touts Exclusivity Voucher

Providing a transferable period of patent-life extension in exchange for US FDA approval of a new antibiotic would incentivize ‘the whole ecosystem’ to find new treatments for emerging diseases, CEO Ian Read says.

Policy Pricing Debate

REMS Abuses: Congressional Panel’s Focus Turns To Federal Trade Commission

During bipartisan, but one-sided, hearing about US FDA’s limited authority to ensure generic drug makers can access restricted distribution reference products for bioequivalence testing, one lawmaker wants to know what FTC is doing about the issue.

Regulation Pricing Debate

Array Withdraws Binimetinib's US Filing On Heels Of Late-Cycle Meeting With FDA

Company explored ‘a number of paths to approval’ with agency, but modest progression-free survival benefit in monotherapy treatment of NRAS-mutant melanoma appears to have doomed the new drug application, which was pulled less than two weeks before advisory committee review.

Regulation Drug Review

Opana ER Panel Urged To Disregard ‘Invalid’ Human Abuse Liability Study

In unusual public hearing, Edwin Thompson, head of the US firm that contract manufactures Endo’s long-acting opioid, tells US FDA advisory committee that intranasal ‘liking’ study violated FDA requirements. Thompson has petitioned the agency to do away with need for human abuse liability studies entirely, asserting they are inherently flawed.

Advisory Committees Drug Safety

PDUFA VI: Pediatrics Group Seeks Earlier And Faster Studies

American Academy of Pediatrics’ legislative proposals for user fee bill also include eliminating automatic orphan drug exemption from Pediatric Research Equity Act study requirements.

Pediatrics Legislation

FDA Moves On Endo’s Opana ER Unlikely To Sweep Up Other Opioids

Shift toward intravenous abuse with the reformulated long-acting opioid, coupled with reports of a serious bleeding disorder and HIV transmission, spurred US FDA advisory committee to recommend regulatory action, which could include new labeling, strict risk management measures or market withdrawal.

Drug Safety Advisory Committees
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