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| SPEAKER |
| Dr. Steven Bauer |
| Chief, Cellular and Tissue Therapy Branch |
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CBER, FDA
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MEETING
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November 2008 |
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| BIOGRAPHY |
Dr. Steven Bauer is the Chief of the Cellular and Tissue Therapy Branch, Division of Cellular and Gene Therapies in the Office of Cellular, Tissue, and Gene Therapies at the Center for Biologics Evaluation and Research (CBER), FDA. As Chief, Steven supervises the CBER scientific staff responsible for reviewing proposed trials of novel biological therapies, product applications, policy development in emerging areas of biological therapeutics such as the biomedical use of human stem cells, and the pursuit of research projects related to the regulatory mission of FDA.
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| TALK |
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Stem Cells and Regenerative Medicine: An FDA Perspective
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| DESCRIPTION |
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Steven's talk will describe current FDA perspectives on scientific issues relevant to stem cells and regenerative medicine, cover development of current FDA approaches to regulatory oversight in this area, and illustrate the roles and responsibilities of the various FDA staff members in review of applications and formulation of policy. The development of regenerative medicine products promises to have a profound impact on public health. This talk will describe how FDA regulates novel technologies to meet the challenge of bringing safe and effective therapies to licensure. The regulatory and scientific approach used in the Office of Cellular, Tissue and Gene Therapies and developed in many parts of the FDA is designed to allow progress in clinical research while assuring, to the best of our ability, patient safety and protection of patient rights.
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