For Immediate Release:
October 22, 2021
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
Today, the FDA began posting materials for the next Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting, happening on Tuesday, Oct. 26. The committee will meet in open session to discuss a request to amend Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age.
On October 19, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American public.
As of today, 419 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 292 molecular tests and sample collection devices, 89 antibody and other immune response tests and 38 antigen tests. There are 66 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, nine antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
The FDA has authorized 16 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 657 revisions to EUA authorizations.
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.
Content current as of: