US FDA Updates Template For OTC COVID-19 Test Development
The US FDA’s most recent update is intended to help test makers provide validation data and other information to the agency for developing at-home diagnostic tests.
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Korean firm investigating how the test was imported and “strengthening contract terms and their enforcement” with distributors to curb “further attempts at illegal importation.” FDA granted an EUA in December for a different test made by firm.
Democrats Markey and Blumenthal say pandemic not only has led to supply shortages but to “predatory and profiteering behavior,” including sales of fraudulent kits or exorbitant prices for approved devices.
US consumers can order up to four rapid antigen tests per household through USPS website, or a phone hotline coming soon. Biden administration, which is working to buy another 500m tests soon, notes more OTC tests are becoming available through an accelerated pathway to support FDA reviews of for emergency use authorizations of tests with potential for large-scale manufacturing.