Coronavirus (COVID-19) Update News: April 7, 2021

The U.S. Food and Drug Administration today announced the following steps for its ongoing response to the COVID-19 epidemic:

The FDA has issued an Emergency Use Approval (EUA) at Symbiotica Inc. For the COVID-19 self-collected antibody test system, the primary serology test reception using approved Symbiotica COVID-19 self-collected blood samples requires a prescription from antibodies. The testing system has been used to help detect if a person has adaptive immunity to SARS-CoV-2, indicating that the person has a recent or previous COVID-19 infection. The samples collected at home are a Symbiotica, Inc. Are sent to the laboratory for analysis.

On April 5, 2021, the FDA issued a new guideline and simultaneously implemented: COVID-19 epidemic - the development of a new drug application brief during Q&A. This guideline provides general recommendations for the development of generic drug products for generic drug applicants and relates to the submission of regulators in the form of COVID-19 obtained and addressed by the FDA in public health emergencies. The FDA is issuing these guidelines in order that the event and application of generic drugs can still evolve COVID-19 publicly health emergencies, ultimately helping to make sure Americans continued access to safe, effective generic drugs.

Test updates:
To date, 355 test and sample collection devices have been approved by the FDA under Emergency Use Authorization (EUAs). These include 258 molecular tests and sample collection devices, 75 antibody and other immune response tests, and 22 antigen tests. There are 43 molecular propositions and 1 antibody endorsement that can be used with samples collected at home. The home test consists of a molecular prescription, two antigen prescription A-home tests, four over-the-counter (OTC) anti-Amazon tests, and an OTC molecular test.

The FDA has approved 6 antigen tests and 1 molecular test for serial screening programs.

The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by assuring the safety, effectiveness, and safety of human and veterinary drugs, vaccines, and other biological products and treatment devices for human use. The company is also responsible for the safety and security of food supplies, cosmetics, dietary supplements, products that block electronic radiation, and tobacco products in our country.