The PFSB inaugurated the Study Group for Early Introduction of Medical Devices and Other Products with Great Unmet Medical Need (tentative) on October 26 in order to more quickly approve medical devices and in vitro diagnostics that are generally available…
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We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…





