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Draft ‘Cures’ Bill Allows Advance Accelerated Approval Agreements

 
• By Derrick Gingery

Latest iteration of House’s 21st Century Cures legislation drops brand exclusivity extensions that had been floated previously.

Sponsors would be able to reach preliminary agreements with FDA for product development through accelerated approval in the House 21st Century Cures discussion draft.

The idea appears to be similar to the non-binding special protocol assessment FDA already employs for some products and could...

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More from United States

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.

Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

 
• By Cathy Kelly

The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.

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A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order.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.

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

More from North America

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

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.