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WHERE MEDICAL INNOVATIONS TAKE FLIGHT

preclinical

FDA changes that are now in effect.

The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the Federal Food, Drug, and […]

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