As the COVID-19 Crisis Settles Begins to Settle into a More “Endemic” State, FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types We were expecting this change – here it is. The U.S. Food and Drug Administration updated its COVID-19 test policy to ensure continued access to tests
FDA Update: A lot is going with the Covid testing. And the FDA is taking a closer look to all the test kits on the market.
A lot is going with the covid testing. And the FDA is taking a closer look to all the test kits on the market. Here are the results of one such FDA testing the “TESTS”. Not All COVID-19 Test Kits are Created Equal. FDA Warning… Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home
FDA Update February 8, 2022 With False Results and Possible Dangerous Sampling Methods, the FDA Advises Consumers to Not Use E25Bio COVID-19 Testing Kits With all the rush to get covid tests on the market some companies always try to circumvent the FDA approval process. Here is one case where the FDA has caught
As the COVID-19 variants surface and spread we are learning that testing methods may be affected and may in fact become ineffective. The FDA is in a race to keep up with the changes… SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests The SARS-CoV-2 virus has mutated over time, resulting in genetic variation in the population
On September 23, 2020, mdi Consultants successfully obtained EUA authorization for our client Jiangsu Well Biotech Co., Ltd.’s “Orawell IgM/IgG Rapid Test”. This is only the 16th rapid antibody test authorized by the FDA to identify the presence of both IgG and IgM antibodies since the EUA period began in March, 2020. Throughout the FDA review