FDA to Issue Emergency Use Authorization for Monkeypox Tests
In a move to expand access to lab testing for monkeypox, HHS has authorized the FDA to issue EUAs for in vitro diagnostic tests for the virus.
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FDA Re-Opens Pre-Submission Requests for Non-COVID-19 IVD Tests
The agency is once more accepting pre-submissions for all in vitro diagnostic tests, not just those for COVID-19.
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FDA to Continue Remote Regulatory Assessments after Pandemic Ends
Meant to be temporary, remote regulatory assessments proved so successful that the agency will not only continue, but expand their use.
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GAO: FDA Needs Policy to Avoid Repeating EUA COVID-19 Test Mistakes
In a recent report, the GAO says the agency needs a policy when it comes to enforcement discretion regarding tests approved via EUA.
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GAO to FDA: Create Emergency Powers Policy to Avoid COVID Mistakes
The agency needs a plan on use of EUA authority to get lab tests to market during the next public health emergency, says the GAO.