People In Brief
This article was originally published in The Gray Sheet
Executive Summary
IDE director departs: FDA has yet to name a replacement for Elisa Harvey, who left her position Sept. 29 as investigational and humanitarian device exemption programs director within CDRH's Office of Device Evaluation. A primary challenge for whoever takes the job, in addition to directing IDE and HDE regulatory policy, will be overseeing the pre-IDE program, where sponsors have the chance to meet with FDA reviewers to get guidance on study design prior to initiating a pivotal trial. FDA staffers have said that pressure to fulfill MDUFMA application review timelines has limited the agency's ability to meet industry's growing interest in pre-IDEs (1"The Gray Sheet" Nov. 21, 2005, p. 9). Harvey spent more than 10 years at CDRH, previously as the review branch chief for peripheral vascular devices and as an Ob/Gyn device reviewer. She started Oct. 2 as a consultant at CardioMed Device Consultants, founded by former FDA interventional cardiology device reviewer Semih Oktay...
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People In Brief
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)...
People In Brief
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)...
MDUFMA II Should Address Pre-IDE Process, Cycle Goals – Stakeholders
FDA should work to improve the process by which companies and the agency negotiate clinical trial designs, several participants argued at the third annual MDUFMA stakeholder meeting Nov. 17