Sue Sutter
Senior Editor

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.
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.
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.
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new opportunities for human error, pharmaceutical industry representatives and data companies say in comments on a draft guidance.
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.
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.