FDA REFORM DEBATE MAY SPUR "MORE INFORMED" OVERSIGHT OF FDA BY CONGRESS, SENATE STAFFER SAYS; PDUFA REAUTHORIZATION HAS SET FIVE-YEAR CYCLE FOR FD&C ACT REVIEW
The FDA Modernization Act's prescription drug user fee sunset creates a "five-year cycle" for review of the FD&C Act, Senate Labor & Human Resources Committee Health Policy Advisor Jay Hawkins told the annual Food & Drug Law Institute meeting Dec. 9 in Washington, D.C.
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A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.