02 03 Inside HSCA: HSCA Releases Statement on PDUFA 04 05 15 16 19 20 21 22 23 24 25 26 27 28 31 32 33

HSCA Releases Statement on PDUFA

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HSCA recently released a statement on the U.S. Senate’s passage of the Prescription Drug User Fee Act (PDUFA) of 2012. In the statement, HSCA President Curtis Rooney applauded the act, and specifically pointed out two provisions addressing critical issues in the healthcare supply chain: prescription drug shortages and the ability to track and recall faulty medical devices through the use of a Unique Device Identifier (UDI).

“Drug shortages are a complex challenge, and HSCA supports the Senate in its efforts to require drug companies to provide FDA early notification of anticipated drug shortages…UDI will help ensure that patients can be quickly located and notified in the event of a device recall and that they do not continue to use devices that may be harmful to their health.”

To read HSCA’s statement, click here.

To read the DOTmed News piece titled, “Device makers, GPOs hail Senate's FDA user fee renewal”, click here.

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