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.
Mercom Capital Group says telehealth VC deals continue to dominate the digital health sector which is poised to break new records this year. Almost half of telehealth investments from the past decade came in just the past year as the world grapples to work remotely during the coronavirus pandemic.