Real-World Evidence User-Fee Funding Praised At FDA Meeting
Patient advocacy groups unanimously thanked FDA and industry for including patient engagement and real-world evidence elements in the new user-fee deal during a Nov. 2 meeting. RWE was initially a point of disagreement during negotiations between FDA and industry, but industry cautiously supported pilot funding.
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CDRH’s Shuren Talks MDUFA, Industry’s Premarket Wants, Emerging Technologies, And More In Wide-Ranging Interview
In an exclusive interview with Medtech Insight, FDA device center director Jeff Shuren said the agency will possibly discuss issues such as postmarket surveillance and patient engagement in upcoming MDUFA negotiations. He also talked about some recent big wins for the agency and his vision for the coming year.
Industry Advocacy Group Goes Global After Device Tax Repeal
After an eleventh-hour win last year that saw Congress repeal the medical device excise tax, AdvaMed is going more global. CEO Scott Whitaker sat down with Medtech Insight for a lengthy chat about what the lobby group will focus on in 2020, including reimbursement challenges, the upcoming medical device user-fee negotiations, and negotiations with governments that are key to the industry ecosystem.
US FDA Toying With Idea Of ‘Regulatory Legos’ In MDUFA V
Noting the latest round of user-fee negotiations are coming up, FDA device center head Jeff Shuren recently floated the idea of developing statutory building blocks – or what he calls ‘regulatory Legos’ – that would allow the agency to keep up with rapidly advancing medtech products. Instead of constantly asking Congress for new statutory authorities as technology advances, he said, the FDA could have broader authority to bring new products not covered under its current authority to market.