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Institute for Alternative Futures

New Report Addresses Potential Benefits and Shortcomings in Development of Risk Evaluation and Mitigation Strategies REMS

Published in Medical Letter on the CDC and FDA, April 18th, 2010

Two years after the Food and Drug Administration Amendments Act of 2007 (FDAAA) gave FDA new powers to require Risk Evaluation and Mitigation Strategies (REMS) for higher risk drugs and biologics, a new report concludes that an optimal future for REMS is possible if the agency adopts a systems approach when designing REMS programs and takes advantage of new technologies -- from electronic medical records to genetic testing -- that are changing the way medicine is practiced.

The result of a September 2009 workshop sponsored by the Society for Women's Health Research and facilitated by the Institute for Alternative Futures, the report -- Optimal Futures for Risk...

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