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Cures Act and the FDA

Obama and the White House provided strong support for the Act. But others, such as Senators Elizabeth Warren (D-MA) and
Bernie Sanders (I-VT), believe that the provisions that may compromise the FDA’s ability to ensure the efficacy and safety of
medical products outweigh the law’s positives. We focus here on the potential changes the Act will have on the regulation of
medical products and the resulting effects on physician and patient trust in the safety and efficacy of those products. Consumers
need to be aware of these changes and must understand that the evidence required for drug approval may be less rigorous that
it has been in the past. This primarily affects newly approved drugs, or drugs with newly approved indications.

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