I know I'm 24 hours late to this gripe, but for the health care editors on this website: THE FDA'S EMERGENCY USE AUTHORIZATION PROCESS DOES NOT CONSTITUTE AN APPROVAL. THE PRODUCT IS NOT APPROVED, IT IS *AUTHORIZED* FOR USE. Ok, normal use of caps follow. Thread: 1/5
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Yeah, I know this seems like semantics. It's not. EUAs apply to a specific public health emergency. After it concludes, the EUA ceases to exist, and the product must be pulled from the market. An approved product remains approved, regardless of the emergency declaration. 2/5
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The standards for "approval" and "authorization" are also wildly different. EUA: "May be effective" Standard approval: "Substantial evidence of safety and effectiveness." 3/5
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Replying to @AlecGaffney
Can data from use under an EUA be used as part of application for approval?
11:24 PM - 30 Mar 2020
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