After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?
Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.
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An advisory committee will discuss whether the agency may consider human studies sufficient to allow reasonable radiation absorbed dose calculations for new PET drugs containing one of six radionuclides in the absence of drug-specific animal dosimetry data.
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.
Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.