The Food and Drug Administration (FDA) has established testing centers for assessment of three categories of medical products; devices, biologics, and drugs. Increasingly, however, medical products are appearing that are combinations of more than one of those categories. The FDA is just beginning to develop procedures for evaluating such combination products, which pose new challenges for assessing efficacy and safety. The Roundtable on Biomedical Engineering Materials and Applications (BEMA) is an NRC activity that brings together relevant parties to discuss R&D, applications, and regulation of biomedical materials and devices. In 2003, BEMA held a workshop to discuss science-based assessment for evaluation of combination products. This report and accompanying CD present abstracts and viewgraphs of the talks given at that workshop. The workshop focused on three specific types of combination products: orthopedic repair using morphogenetic protein, drug-eluting stents, and cell-matrix cartilage implants. In addition, context-setting discussions of science-based assessment and experimental design were presented at the workshop.
Table of Contents
|1 Setting the Context||1-8|
|2 Science-Based Assessment and Experimental Design||9-13|
|3 Bone Morphogenetic Proteins and Orthopedic Repair||14-17|
|4 Drug-Eluting Stents||18-20|
|5 Cell-Matrix Cartilage Implants||21-26|
|APPENDIX A: Workshop Agenda||27-30|
|APPENDIX B: Biographies of Speakers and Session Chairs||31-38|
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