One of the first jobs the US Food and Drug Administration’s new inspections council will take on is developing policy around the agency’s use of Remote Regulatory Assessments.
The US Food and Drug Administration announced on Friday that it has issued two final orders reclassifying certain hepatitis C diagnostic tests from Class III to Class II. Additionally, it reclassified blood lancet devices from Class I to Class II and Class III.
The US Food and Drug Administration on Monday released revised guidance on its regulatory priorities and policies for COVID-19 tests.
The funding will be used to provide purchase commitments to manufacturers so they can scale up test production.
Meridian Bioscience announced on Wednesday that its Revogene SARS-CoV-2 test has received Emergency Use Authorization from the US Food and Drug Administration.
Britain said it would recognise COVID-19 vaccines on the World Health Organization's Emergency Use Listing later this month.
The US Food and Drug Administration on Thursday said it has granted Emergency Use Authorization for Detect's over-the-counter, at-home SARS-CoV-2 test.
The US Food and Drug Administration last week granted Emergency Use Authorization for InBios International's SCoV-2 Detect Neutralizing Ab ELISA immunoassay for SARS-CoV-2.
Cell fitness has been identified as a way of predicting health outcomes in COVID patients, according to a University of Queensland study.
The US Food and Drug Administration last week granted Emergency Use Authorization for Lighthouse Lab Services' CovidNow SARS-CoV-2 Assay.
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