JoAnne Less: A New Director for FDA’s Office of Combination Products

Combined drug-devices are tremendously innovative, but often challenge companies to come up to speed on, and meld, two separate sets of regulations. FDA just sent notice that the former chief of the Office of Combination Products has resigned to join industry.  Below is more information on the new chief, from FDA. Mark Kramer has resigned as FDA's Director of the Office of Combination Products (OCP). After 14 years of service to the FDA, Mark has decided to pursue a wonderful opportunity with industry. I know that he will take with him all the knowledge and expertise that he has accumulated over the years here, but more importantly, what was truly intuitive to Mark - his incredible work ethic, loyalty and dedication to this Agency and the American public. Although Mark will be sorely missed, I know you all join me in wishing him the very best of luck in his new endeavors. At the same time, I am delighted to announce that as of April 1, Dr. Joanne Less became Acting Director of the Office of Combination Products. For those of you who perhaps do not know Joanne, let me tell you a little about her. Joanne is presently the Associate Director for Clinical Research and Government Affairs in the Center for Devices and Radiological Health and is that Center's expert on the laws, regulations, and polices governing the clinical investigation of medical devices, particularly those related to human subject protection. During her tenure in CDRH, she has been heavily involved in various legislative implementation and "transformation" activities, including FDAMA, CDRH's reengineering efforts, efforts to address the paucity of pediatric medical devices, and MDUFMA, as well as participating in the MDUFMA II negotiations. Joanne served as the Director of the Investigational Devices Exemption and the Humanitarian Device Exemption Programs in the Office of Device Evaluation in CDRH for almost 10 years. She joined the Agency in 1992 as a scientific reviewer in the Division of General and Restorative Devices. Joanne received a B.S. in Chemistry from the College of William and Mary and received a M.S. and Ph.D. in Biomedical Engineering from the University of Virginia. After completing her doctorate, she served as an Assistant Professor in the Department of Surgery at the University of Pittsburgh and a Visiting Scholar in the Department of Chemical Engineering at Carnegie Mellon University.
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