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Woodcock: Use Of Real-World Evidence Still Brings ‘A Lot Of Problems’

US FDA acting commissioner Janet Woodcock says the use of real-world evidence in product reviews will be slower than many of its supporters are hoping because there are a number of problems that still need to be addressed.

CDER Dir. Janet Woodcock at Reagan-Udall Foundation for FDA.(2)
Janet Woodcock, now FDA acting commissioner, at a Reagan-Udall Foundation for the FDA event in 2019 • Source: Ferdous Al-Faruque

Janet Woodcock, the acting commissioner of the US Food and Drug Administration, says that the use of real-world evidence (RWE) in product reviews will be slower than many of its supporters are hoping because there are a number of problems that still need to be addressed.

Woodcock spoke with Pamela Goldberg, CEO of the Medical Device Innovation Consortium (MDIC), at MDIC’s 2021 Annual Public Forum on 1 June, where she was asked about the FDA’s ongoing...

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