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This article was originally published in The Gray Sheet

Executive Summary

FDA ODE deputy director departs: FDA's Office of Device Evaluation's Deputy Director for Engineering and Science Review Miriam C. Provost will become a senior project manager at regulatory consultants M Squared Associates in Alexandria, Va. Sept. 4. There is no word yet on her replacement at the agency. Provost, a 13-year veteran at FDA, has jumped around within ODE in recent years, switching between acting director for the Division of General, Restorative and Neurological Devices (DGRND) and acting associate director of ODE in 2005 before taking on her current post last year. Previously she served as a deputy director for DGRND and as a reviewer for gastroenterological and renal devices. Provost is likely to run into another former FDA colleague at M Squared, senior project manager Dina J. Fleischer, a 16-year FDA veteran and former chief of the circulatory support and prosthetics devices branch who left FDA on Nov. 2 and joined M Squared on Nov. 6. Provost and Fleischer are also joined by Elisa Harvey among recent departures from the device review office to the private sector (1"The Gray Sheet" Oct. 2, 2006, p. 9)...

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J&J regulatory affairs: Robert O'Holla retires in April from his position as VP-regulatory affairs for Johnson & Johnson's device and diagnostics segments after more than 30 years with the company. O'Holla has held his current position since 1990. Dorothy Clarke has been transitioning to fill his role since February, with the new title of VP-regulatory affairs for the Comprehensive Care and Surgical Care units, housing most of J&J's device businesses following a restructuring last November (1"The Gray Sheet" Nov. 19, 2007, p. 11). Clarke was previously a legal VP at Ethicon and assistant general counsel for the J&J device and diagnostics legal group

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J&J regulatory affairs: Robert O'Holla retires in April from his position as VP-regulatory affairs for Johnson & Johnson's device and diagnostics segments after more than 30 years with the company. O'Holla has held his current position since 1990. Dorothy Clarke has been transitioning to fill his role since February, with the new title of VP-regulatory affairs for the Comprehensive Care and Surgical Care units, housing most of J&J's device businesses following a restructuring last November (1"The Gray Sheet" Nov. 19, 2007, p. 11). Clarke was previously a legal VP at Ethicon and assistant general counsel for the J&J device and diagnostics legal group

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