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    Stem Cell-based Therapies and FDA Regulations

    Stem cell-based therapies are arriving in the clinic as Phase 1 studies. Which technological challenges and US Food and Drug Administration (FDA) regulations govern the development and translation of stem cell therapies into medical treatments? Irving Weissman, MD, PhD, discussed the current and future caveats of bringing stem cell therapies to clinical trials at the Institute of Stem Cell Biology and Regenerative (ISSCR) conference in San Francisco on 15 June 2010. "W...
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    Regulatory Information and Intelligence Tools: Devices

    It is important to have the right tools and resources for information about medical device regulations. The tables in this article offer a quick listing of pertinent information online that can be accessed at any time. We will take you on a tour of discussion groups, blogs, journals, newsletters, education services, regulatory informational databases, professional and trade organizations, regulatory affairs service providers and sites to visit, many of which includea lot...