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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’s Molecular Target Lists Face Panel Vetting

In addition to reviewing proposed lists of targets for relevance to pediatric cancer, advisory committee will discuss possible criteria for prioritizing same-in-class agents for evaluation and ways to promote international collaboration and global development; proposed list of substantially relevant targets is growing.

Advisory Committees Pediatrics

Mylan's Fulphila Approval: Lack Of US FDA AdComm May Be A Positive For Biosimilar Industry

The advisory committee route for approving a first biosimilar to a reference product is no longer necessarily the norm, going by FDA's recent approval of Mylan/Biocon's pegfilgrastim-jmdb, which references Amgen’s Neulasta; agency’s view that a meeting was not needed should encourage other biosimilar aspirants.

Biosimilars Advisory Committees

Posting Preapproval Access Policies Could Help Prevent ‘Blame And Shame’ Under Right To Try

Many biopharmas have not publicly posted their policies for evaluating and responding to expanded access requests as required under the 21st Century Cures Act. Putting this information out will help set patient community expectations, but will not viewed by US FDA as off-label promotion, experts say at BIO annual meeting.

Legislation Clinical Trials

Why The Right-To-Try Law Is Not Right For Some Biotech Companies

Two CEOs explain why their rare disease companies will not grant preapproval access to investigational drugs under new federal law; Alnylam sees no need for framework beyond FDA’s expanded access pathway, while Sarepta is focused on the ‘grand goal’ of getting drugs studied and approved for the patient community.

Rare Diseases Clinical Trials

US FDA’s Plan On Right To Try: Big On Congressional Engagement, Short On Policy Details

Internal group headed by Principal Deputy Commissioner Rachel Sherman will develop implementation recommendations, which could include new guidance, regulations, a Q&A document or ‘nothing at all,’ Commissioner Gottlieb tells BIO annual meeting; he promises consultation with the law’s supporters and critics on Capitol Hill ‘to fully understand what the intent was with different provisions.’

Legislation FDA

Generic Company Disclosure Could Be A 'Speedbump' Against Misuse Of US FDA Access Inquiry List

Generic companies might get more transparency than they bargained for if there is misuse of the public list of reference drugs they say they have trouble obtaining; at BIO annual meeting, FDA Commissioner Gottlieb also suggests VA procurement of brand drugs as possible alternative if innovators continue to hinder access for bioequivalence testing.


Generic Drugs Pricing Debate
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