Silver Spring, MD – The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
As Pfizer has announced External Link Disclaimer, the FDA has formally accepted the company’s Biologics License Application (BLA) requesting licensure (approval) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 Coronavirus in individuals 16 years of age and older and has granted the application priority review.
Currently, the vaccine is authorized for emergency use to prevent COVID-19 coronavirus in individuals ages 12 and older.
The Prescription Drug User Fee (PDUFA) Goal Date of January 2022 reflects the PDUFA deadline for Priority Review and does not mean approval will not happen before that time.
Quite to the contrary, the review of this BLA has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the PDUFA Goal Date.
The FDA has created new product codes for certain medical devices authorized for emergency use under Emergency Use Authorizations (EUAs). An applicable product code has been assigned to each authorized device category. The product codes are listed in the tables for each category of devices that have EUAs.
The categories of devices are available on the Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices page.
As of today, 396 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 281 molecular tests and sample collection devices, 85 antibody and other immune response tests and 30 antigen tests. There are 52 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, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
The FDA has authorized 11 antigen tests and seven molecular tests for serial screening programs. The FDA has also authorized 576 revisions to EUA authorizations.
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (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.