The US Food & Drug Administration will have one year to outline a new “Platform Technologies” pathway for sponsors hoping to streamline development of products that rely on a common backbone (like a vector for gene therapies) to treat different diseases under the year-end spending bill expected to be enacted in the coming days.
Sen. Burr’s Parting Gifts For US FDA Include ‘Platform’ Pathway
The year-end package of US FDA reforms reflects the impact of one now-retired US Senator: North Carolina’s Richard Burr’s objections helped take out a number of ‘anti-innovation’ provisions – while still securing inclusion of a ‘Platform Technologies’ pathway that might otherwise not have been enacted.
