FDA News Release
FDA Roundup: March 11, 2022
- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA issued the Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions Guidance for Industry. The enforcement discretion policies announced today are specific to provisions in the following rules: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Animal Food; Foreign Supplier Verification Program (FSVP), Produce Safety (PSR) and Intentional Adulteration (IA).
- As part of the FDA’s effort to protect consumers, on March 7, the agency issued a warning letter jointly with the Federal Trade Commission to Viraldine, LLC for selling unapproved products with fraudulent COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
- On March 4, the FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, from six to nine months, allowing the product to be stored at 2-8 degrees Celsius. This extension was granted following a thorough review of data submitted by Janssen, now applying to all refrigerated vials of Janssen COVID-19 Vaccine that have been held in accordance with the manufacturer’s storage conditions. A copy of the concurrence letter is posted on FDA’s website.
- COVID-19 testing updates:
- As of today, 421 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 291 molecular tests and sample collection devices, 85 antibody and other immune response tests and 45 antigen tests. There are 70 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 14 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 25 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 875 revisions to EUA authorizations
- Update: The FDA updated this safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in dark blue packaging is a product of ACON Biotech (Hangzhou) Co., Ltd.
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.
- FDA Office of Media Affairs