New RWE Framework Aims To Get IVDs To Market Faster, Surveil COVID-19 Tests
Three years after the US FDA released a guidance to use real-world evidence in premarket applications, the stakeholder group MDIC has unveiled a framework for how IVD RWE can be captured and used by sponsors for premarket applications.
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MDIC Proposes Real-World Evidence Framework For Sponsors To Hasten Product Applications
The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.
J&J Chief Medical Officer To Lead MDIC Board Of Directors
Jijo James, a top Johnson & Johnson executive, will succeed CVRx CEO Nadim Yared as the next chair of MDIC next summer.
Day 1: US FDA Launches New 'Super Office,' Says It’s Already Proven Its Worth
Speaking at MedCon 2019, CDRH Director Jeff Shuren announced 1 May is officially the first day for the agency’s new Office of Product Evaluation and Quality. The agency lists several examples of how it has already been used in a pilot setting to remove potentially harmful products from market sooner, and resulted in more efficient and safer product reviews.