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A Question Of Intent: How To Avoid US FDA Pitfalls With Academic Oncology Trials

 
• By Michael McCaughan

Academic oncology centers and commercial sponsors should work together to ensure that studies begun without ‘registrational intent’ can nevertheless work for US FDA’s needs if circumstances change, a multi-stakeholder white paper urges.

pitfalls in cancer research
• Source: Shutterstock

Biopharma companies should proactively plan for the possibility that academic trials involving their products begun without “registrational intent” could nevertheless generate data that ends up being submitted to the US Food & Drug Administration, a Friends of Cancer research white paper advises.

Key Takeaways

  • Trial sponsors should communicate with FDA as quickly as possible when they realize an academic trial may have a regulatory goal after all.

The white paper, developed by a multi-stakeholder panel that included FDA input, was one of a series prepared for...

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• By Eliza Slawther

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Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
• By Sue Sutter

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.

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Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

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LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.