Industry News

President Signs FDA Safety and Innovation Act

July 10, 2012


On July 9, 2012, President Obama signed into law the Food and Drug Administration (FDA) Safety and Innovation Act (S.3187). The law revises and extends the user-fee programs for prescription drugs and medical devices, and establishes user-fee programs for generic drugs and biosimilars. Furthermore, the legislation aims to modernize FDA authority and improve patient safety. The law includes a requirement that commercial drug importers register with the Department of Health and Human Services. Commercial drug importers may also be required to submit additional compliance information. The included industry user fees are expected to fund a part of the FDA’s review of drugs and medical devices.

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