FDA Week - 07/12/2019

FDA Yet To Answer Senators’ Letter On Progressive Approval Device Path

By David Roza
July 10, 2019 at 11:41 AM
Sen. Elizabeth Warren (D-MA) is still waiting for a response from FDA to a letter she and Sen. Patty Murray (D-WA) wrote last month raising concerns with a new device approval pathway proposed in the agency’s fiscal 2020 budget justification. The proposed pathway would allow FDA to approve devices intended to treat life-threatening illnesses for a limited period of time based on a demonstration of safety and performance. The proposed device pathway, known as progressive approval, is similar to the...

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