Bodysphere EUA Blunder Is A Lesson In What Not To Do
Meanwhile, some are questioning whether Bodysphere is a legitimate company
Hold back on bragging about your emergency use authorizations until you have them in hand, says one expert after diagnostics company Bodysphere had to backtrack its EUA announcement due to a misunderstanding with the US FDA.
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Ready, Set, Go: ‘Unprecedented’ FDA Guidance Aims To Unburden Coronavirus Test Makers, Speed Process
The US agency issued a guidance document that significantly lowers regulation of diagnostics used specifically to fight the ongoing COVID-19 pandemic. The new policies give states far more autonomy, allow diagnostics makers to distribute products before an Emergency Use Authorization is issued by the FDA, and permits certain serological tests on the market if they adhere to proper labeling.
To be more transparent and allow more public discourse, the HHS now requires all its agencies to publish documents it uses to rationalize proposed rules and demonstration projects.
The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.