Congress has passed the Food and Drug Administration Safety and Innovation Act, which includes language to set in motion regulation of health information technology, and has sent the bill to President Obama for his signature.

The bill has many changes for the FDA, particularly in setting manufacturer user fees that pay for regulation of drugs, devices and biological products, along with provisions to better manage drug shortages. For instance, it enables delivery systems to repackage drugs in shortage and distribute them to affiliate hospitals, and requires FDA to list drugs in shortage by name and NDC code, among other provisions. The legislation also sets deadlines for establishment of unique medical device identifiers.

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