- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA issued an Emergency Use Authorization (EUA) to Symbiotica, Inc., for the COVID-19 Self-Collected Antibody Test System, making it the first serology test authorized for use with a blood sample self-collected at-home. The Symbiotica COVID-19 Self-Collected Antibody Test System requires a prescription from a health care provider. The test system is intended to aid in identifying if a person has had an adaptive immune response to SARS-CoV-2, indicating that the person may have had a recent or previous COVID-19 infection. Samples collected at home are sent to a Symbiotica, Inc. laboratory for analysis.
- On April 5, 2021, the FDA issued and immediately implemented a new guidance: Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers. The guidance provides general recommendations to prospective generic drug applicants related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by the FDA during the COVID-19 public health emergency. The FDA is issuing this guidance so that the development of generic drugs and submission of applications can continue during the COVID-19 public health emergency, ultimately helping to ensure that Americans continue to have access to safe, effective generic drugs.
- Testing updates:
- As of today, 355 tests and sample collection devices are authorized by the FDA under emergency use authorizations (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 authorizations and 1 antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home test, four over-the-counter (OTC) at-home antigen test, and one OTC molecular test.
- The FDA has authorized 6 antigen tests and 1 molecular test for serial screening programs.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.