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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.

Latest From Sue Sutter

Accelerated Approvals Need Earlier Planning On Surrogate Endpoints, Postmarketing Trials – FDA’s Marks

Current accelerated approval provisions are the ‘sweet spot’ for balancing access and efficacy, but more attention needs to be paid by sponsors and the agency to working out regulatory pain points earlier in the development process, CBER director tells gene/cell therapy conference.

Gene Therapy Review Pathway

Pediatric Cancer Studies: US FDA Eyes Waiver Framework For Same-In-Class Drugs

Advisory committee says planned waivers for molecularly targeted studies should take into account comparative adult efficacy and toxicity data for multiple drugs in the same class, as well as differences in product attributes, such as route of administration and dosing schedule; unmet clinical need should have less influence on decision to grant waivers, panelists said.

Advisory Committees Pediatrics

US FDA Aims To Simplify Terminology For Remote Assessments

The use of various acronyms – including RRA, RIE and RRR – to describe remote assessments of sites and study data has been confusing and makes it sound as though people are speaking ‘like a pirate,’ Office of Study Integrity and Surveillance director Sean Kassim says.

FDA Manufacturing

US FDA’s Current Technical Standards Not A Good Fit For Real-World Data, Stakeholders Say

The agency’s existing technical standards are better-suited to clinical trial data, and mapping RWD to these formats will result in the loss of granularity and introduce new opportunities for human error, pharmaceutical industry representatives and data companies say in comments on a draft guidance.

Real-World Evidence Guidance Documents

US FDA Aims To Simplify Terminology For Remote Assessments

The use of various acronyms – including RRA, RIE and RRR – to describe remote assessments of sites and study data has been confusing and makes it sound as though people are speaking ‘like a pirate,’ Office of Study Integrity and Surveillance director Sean Kassim says.

Clinical Trials Generic Drugs

Artificial Intelligence Is Future Of Postmarketing Surveillance, US FDA’s Marks Says

CBER director’s vision for a national safety surveillance system includes use of AI and natural language processing to enable near-real time signal detection from adverse event reports.

Artificial Intelligence Vaccines
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