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Ex-FDAer Phillips enters consulting ranks

This article was originally published in The Gray Sheet

Executive Summary

Former ODE Science & Regulatory Policy Deputy Director Phil Phillips joins Becker & Associates Consulting as director of the firm's medical device practice. The Washington, D.C.-based company provides regulatory and marketing support to healthcare firms. Phillips, who joined FDA in 1981, had served as a liaison between ODE and the Office of Science & Engineering Laboratories before leaving in February (1"The Gray Sheet" Feb. 28, 2005, p. 11)...

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CDRH director's plea to industry: Device center director Dan Schultz urges companies submitting complementary applications to CDRH to "get together and share information between themselves" in order to facilitate the review process. During a recent Food & Drug Law Institute meeting, he recalled FDA's review of Amplichip, which consisted of separate applications submitted by Roche and Affymetrix. Schultz noted: "One of the things that made this a little bit challenging for us was that those two companies really weren't talking to each other very much and we had to review the two separate applications essentially separately and sort of put them together ourselves and try to make sure that we had them cleared at roughly the same time." He added: "Recognizing that we are going to be seeing more and more of these products come in as combinations or as products that are being used together, the extent that industry can get together and share information between themselves...and share it with us, would really make our lives a lot easier"...

Office Of Device Evaluation Deputy Director Phillips Departs FDA

FDA's Office of Device Evaluation has yet to reveal whether it will name a new deputy director for science & regulatory policy, following the Feb. 18 departure of device center veteran Phil Phillips

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Stephen Hahn’s low visibility period as the newly installed FDA commissioner comes to an abrupt end. Trump offers generous praise amid COVID-19 response – but how quickly might that change to blame?




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