Predicting The User Fee Reauthorization Schedule

PDUFA and GDUFA negotiations are expected to begin first, as they usually take the longest to complete, and will be followed by BsUFA talks.

User Fee Reauthorization Preview 2020
Industry and US FDA officials likely will meet for months to hammer out the agreements needed to reauthorize the three user fee programs. • Source: Pink Sheet illustration

The US Food and Drug Administration hasn't announced the initial public meetings to discuss the structure of the next iterations of the user fee programs, but a look at the last two cycles suggests that they could be scheduled for late spring or mid-summer.

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FDA Layoffs: US Likely To Lose Its First Approver Advantage

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

 

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

 

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

 

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?

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EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 

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

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The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to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

 
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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.