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Proposed FY 2024 Applications for New Technology Add-On Payments (Alternative Pathways) As discussed previously, beginning with applications for FY 2021, a medical device designated under FDA's Breakthrough Devices Program that has received marketing authorization as a Breakthrough Device, for the indication covered by the Breakthrough Device designation, may qualify for the new technology add-on payment under an alternative pathway

Its a bit like trying to pump up a tyre - it's quite easy when there isn't air in the tyre but gets more difficult as the tyre pumps up with air

Biomacromolecules 19 , 28892895 (2018)

10.1016/j.ijid.2021.03.032 150 PareekM.GreenawayC.NooriT.MunozJ.ZennerD

However, the rate of plasma clearance of synthetic deuterium labeled forms of these trimethylamines were not remarkably different compared to BB (Figure S2)