US Senate passing of FDA Safety and Innovation Act lauded by biotech and pharma industry

28 May 2012

The US Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA), last Thursday, in a move welcomed by both the Biotechnology Industry Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA).

BIO president and chief executive Jim Greenwood commented: “The inclusion of an enhanced Accelerated Approval pathway, crafted by Senator Kay Hagan (Democrat, North Carolina), will help expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases while preserving the FDA’s robust standards for safety and effectiveness.

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