In Law360: FDA Faces Uncertainty Implementing 21st Century Cures Act

March 15, 2017 - The article, "FDA Faces Uncertainty Implementing 21st Century Cures Act" was published in Law360.

One of the last bills President Barack Obama signed into law was the 21st Century Cures Act, sweeping legislation intended to accelerate the development and delivery of “21st century cures.” The act promotes innovative projects, supports state efforts to curb opioid abuse, promotes the discovery of new medical products, and accelerates U.S. Food and Drug Administration approval of new medicines and medical devices.

The act sailed through Congress with broad bipartisan support, and the FDA stood ready to implement its provisions. Three months later, however, uncertainties created by two presidential actions — the 90-day hiring freeze and the “one in, two out” executive order — have stalled the act’s implementation.

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