Word: fda
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...January of this year, two state officescomplained to the FDA that Israel planned tomarket the decelerator. The offices also allegedthat the machine misfires and causes seriousburns...
...Boston office of the FDA investigated andfound no evidence of commercial distribution,misfirings or burns, according to a statementprovided by the FDA...
...interview, an FDA spokesperson saidBRI's cooperation with the agency has beencomplete and its documentation through...
...letter written March 1 and obtained byThe Crimson, the FDA requested additionalinformation about the decelerator and thestructure of the studies BRI is conducting...
According to this recent letter, the FDA hasdetermined "it is in the best interest of thepublic health that [BRI's] studies be conducted inaccordance with the full requirements of theInvestigational Device Exemptions regulation," asopposed to less thorough pre-market approvalprocess...