Compounding/Track And Trace Bill Another Victim Of Shutdown
This article was originally published in The Pink Sheet Daily
The stripped down version will generate considerably less user fee revenue for FDA, but so far it has met the same fate in the Senate as other recent legislation coming from the House.
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The agency would retain 8,180 staff members, about 55% of its total, mostly because they could be “paid from carryover funding.”
HELP Committee leaders Harkin and Alexander write letter arguing that FDA’s warnings of more problems from tainted compounded medications have come true and that their legislation should gain a vote next month.
The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.