FDA Decisions: Approvals, Rejections and Advisory Votes

A release is listed here when its headline reports an FDA decision. That covers an approval or anything else that lets a product be sold or used outside a trial, such as a 510(k) clearance, a De Novo grant or an emergency use authorization, and it also covers a complete response letter, which the FDA sends when it will not approve an application in its present form, and the vote of an FDA advisory committee, the outside experts the FDA asks for advice. Clearance to start a trial, an accepted application, and orphan drug or fast track designations are not decisions of this kind, so we list them on the clinical trial news page instead.

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