Newgene-US Bioengineering is pleased to announce that it is nearly finished assembling a team of experts to compile and submit requests to the FDA for Emergency Use Authorizations &/or 510(K) certifications for its fast tests for Covid-19 and influenza. Newgene-US is an American company that has an agreement with the manufacturer to import the tests, as well as apply for these approvals, in its own name. The expectation is that the specialized team being assembled will be able to drastically reduce the usual FDA time for issuance of approvals. In addition, the goal is for the approvals to be for self-testing without the requirement for prescriptions. Because human factors are taken into consideration for self-tests, and our tests are very easy to perform, it is not anticipated that getting these sorts of approvals will not be overly tedious.
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