Cures Law Requires FDA, HHS to Harmonize Regs

December 21, 2016

(Bloomberg BNA) – Any discrepancies in how the FDA and the HHS regulate human subject research must be resolved over the next three years under a new requirement in the 21st Century Cures law. The biomedical innovation law, which President Barack Obama signed Dec. 13 (Pub. L. No. 114-255), seeks to spur development and approval of new drugs and devices to get them to patients more quickly. While much of the conversation on Cures focused on the billions of dollars in new research money, lawmakers also aimed to remove administrative burdens so scientists can spend more time on their research and less time on paperwork.

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