1. Pink Sheet
  2. >>Pathways & Standards
  3. >>User Fees

Accelerated Approval, Clinical Trial Diversity Provisions Left Out Of Senate User Fee Bill

 
• By Brenda Sandburg

Two of the most prominent features of the House package are not addressed in the Senate measure, which predominantly focuses on cosmetics, dietary supplements and laboratory developed tests. The absence of competing proposals suggests a smooth conference process.

Capitol ven diagram
There's not much overlap in the content of the House and Senate user fee bills. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock image

The draft Senate bill reauthorizing US Food and Drug Administration user fee programs is strikingly different from the House version, as it does not address the accelerated approval pathway or clinical trial diversity, two of the most significant provisions in the House measure.

More from User Fees

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

 
• By Sarah Karlin-Smith, Elizabeth Orr, and Derrick Gingery

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations

 
• By Derrick Gingery

FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.

US FDA Commissioner Nominee Recruiting More Hill Staff Ahead Of User Fee Reauthorization

 
• By Michael McCaughan

Republican congressional staffers could bring a wealth of experience and strong contacts with key legislators to the FDA ahead of the next user fee reauthorization process. But will Health and Human Services Department leadership interfere?

More from Pathways & Standards

EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 
• By Neena Brizmohun

Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.

Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
• By Sue Sutter

The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.

Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

 
• By Kate Rawson

A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.