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Oncology Accelerated Approval Re-Reviews: US FDA’s Pazdur Is Not Backing Down

 
• By Michael McCaughan

How has FDA suddenly been able to enforce accelerated approval commitments in oncology? The agency’s Richard Pazdur reflects on lessons from 2021 – and promises more re-reviews to come.

Flipping calendar (Alamy)
ODAC may start having annual meetings about "dangling" accelerated approvals. • Source: Alamy

The US Food and Drug Administration’s Oncology Center of Excellence is planning to make reviews of “dangling” or “delinquent” accelerated approvals a routine agenda topic for the Oncologic Drugs Advisory Committee to build on the momentum toward assuring timely confirmatory study results that it established in 2021.

“This is my Jihad,” OCE Director Richard Pazdur said during a Zoom panel discussion as part of the Prevision Policy/Friends...

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US FDA’s ANDA Prioritization Pilot Encouraging Production Onshoring

 
• By Dave Wallace

The latest incentive for firms to move manufacturing to the US is an FDA pilot program that will prioritize the review of US-manufactured and tested ANDA products.

Rese-Cel CAR T Therapy Secures EMA PRIME Designation

 
• By Neena Brizmohun

Cabaletta’s rese-cel is among the latest investigational drugs that have won a place on the European Medicines Agency priority medicines scheme. Meanwhile, 11 products were denied PRIME designations.

Shutdown Approaches: US FDA Would Retain Most Of Recently Trimmed Staff

 
• By Derrick Gingery

FDA shutdown plans indicate about 86% of staff would be retained, a rate that is higher than previous plans, but reserve funding would not last more than a few months.

US FDA Review Teams Face ‘Herculean’ Shift to Two-Month Timelines With New Voucher

 
• By Sue Sutter

The FDA is talking with cell and gene therapy staff about the importance of review timeline alignment for products accepted into the Commissioner’s National Priority Voucher program, CBER’s Katherine Szarama said.

More from Pathways & Standards

October US FDA User Fee Goals: Few Novel Agents, But Many New Indications As Shutdown Looms

 
• By Bridget Silverman

October is unusually low on user fee goals for novel agents, but more than 20 applications for new indications and formulations will keep FDA staff busy, especially in oncology and ophthalmology.

Europe’s EDQM To Help New African Medicines Agency Boost Quality Framework

 
• By Neena Brizmohun

Drawing on around 60 years of experience, the European Directorate for the Quality of Medicines & HealthCare will help the newly formed African Medicines Agency develop robust quality control systems.

US FDA’s Tidmarsh Takes On Surrogate Endpoints, Maybe Old Business Partner, On LinkedIn

 
• By Sarah Karlin-Smith

CDER Director George Tidmarsh said in a now deleted social media post that his center will evaluate surrogate endpoints. Tidmarsh mentioned "notable failures," including a lupus drug, where he has past business connections to the sponsor's board chair.