MDIC Snags $3m For FDA Real-World Evidence Coordinating Center
Executive Summary
FDA has awarded the Medical Device Innovation Consortium $3 million to create a "coordinating center" to develop an envisioned National Evaluation System for health Technology, which will leverage real-world evidence to support device approvals and safety and performance tracking.
You may also be interested in...
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.
Former Zimmer Biomet Exec To Head Clinical Affairs At MDIC
Jing Xie has moved from Zimmer Biomet to the Medical Device Innovation Consortium to serve as the public-private partnership's first VP of clinical affairs.
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.