CDRH staffers becoming less "risk-averse" in reviewing applications -- ODE's Phillips.
This article was originally published in The Gray Sheet
Executive SummaryDEVICE CENTER MANAGEMENT'S COMMITMENT TO "SHIELD" REVIEWERS FROM CRITICISM has made staffers less "risk-averse" in evaluating applications in the past few years, Philip Phillips, deputy director of FDA's Office of Device Evaluation, stated May 4 at a conference in Bethesda, Maryland. Noting that device center staffers became "very risk-averse" in the early 1990s following the generic drug scandal and a period of intense oversight, Phillips said that their concerns have decreased since then because Center for Devices and Radiological Health management has "committed to shield reviewers from any kind of criticism for making a scientific recommendation."
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