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Boston University




You can tell from remarks by prior speakers that regulatory approvals and liability prevention are of critical importance to progress in biomaterials. Gene therapy trials and the tragic outcomes of some of those trials have raised the specter of government suspension of clinical studies, termination of funding, and potential liability for personal injury under malpractice or products liability doctrines. Regulatory requirements and the terms of research grants and contracts have to be very carefully addressed by organizations testing, developing, making, selling and using biomaterials, biotechnology, and medical devices. However, many regulatory requirements are incomplete, ambiguous and confusing because the agencies have not fully formulated coherent regulatory policies and coordinated procedures. Nevertheless, today we are going to do our best to learn what needs to be done to satisfy regulators and, later, to determine how to best address the threat posed by liability as exemplified by recent Dow silicon breast implant litigation1 and DuPont "TMJ Implants" litigation.

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