MDUFA V: FDA Looks For More User-Fee Investments; Industry Wants To Work With What’s There
US FDA commissioner Stephen Hahn argued on 27 October that his device center should consider more user-fee investments to alleviate the agency’s workload and address new innovations – but industry wants the FDA to finish hiring and work with what’s there.
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The US FDA and industry stakeholders are set to finally start monthly user fee negotiations online by February. The process has already been significantly delayed due to the pandemic and recent holidays.
Experts say either would likely prioritize issues such as the coronavirus pandemic and the medical supply chain, but they would diverge in areas like laboratory developed test reform.
The agency says it has sent letters to dozens of companies that have made ‘FDA Registration Certificate’ claims or used the agency’s logo without authorization, which could lead customers to think the products have been vetted.