News and Insights
PDUFA V – A Step in the Right Direction
In a Congressional cycle paralyzed by partisan gridlock, early reauthorization of PDUFA — the user fee act for drugs — was hailed as a triumph for the current Congress. Not only did the law pass with bipartisan support, it passed ahead of schedule. So why was this particular piece of “must-pass” legislation able to garner the nearly unanimous support of Congress, the FDA, Big Pharma, and lobbyists alike?
Innovation in drugs and medical devices has been a crown jewel for the U.S. economy, and ensuring that the FDA can continue to add resources and reduce the time it takes to approve a product is a cause that even as divided a group as Congress can rally behind. Understanding what’s included in the FDA Safety and Innovation Act (FDASIA) and its ramifications for the larger medical products market, will be critical to preparing for the implementation of the law this October.Read More
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