House-Passed '11 Cuts Would Hurt Device Innovation, Pallone, Sebelius Agree
This article was originally published in The Gray Sheet
The leading Democrat on a House subpanel argued during a budget hearing last week that Republican plans to slash federal spending would harm medical device innovation.
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CDRH Director Jeffrey Shuren called out industry during a Feb. 17 House subcommittee hearing for playing a significant role in causing delays in pre-market device reviews.
For a select few devices per year, FDA says it will speed up pre-market development times by intensifying staff efforts, with a particular focus on very early-stage, frequent interactions with product sponsors.
Operation Warp Speed will hold back initial shipments to ensure two-dose regimens can be completed; 15 December is ‘chalk’ target date for emergency authorization of Pfizer vaccine, OWS’ Gustave Perna says, calling it only a projection that does not impinge on FDA authority. Sending only half shipments also eases burden on cold shortage capacity at state and local level, he says.