FDA News Release
FDA Roundup: February 18, 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 is announcing that it has found an additional four lots of AstraZeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. The AstraZeneca vaccine is not authorized for use in the U.S., but the FDA understands that these AstraZeneca lots, or vaccine made from these lots, may now be exported for use. The agency conducted a thorough review of facility records and the results of quality testing performed by the manufacturer and reached its decision based on this review, taking into consideration the current worldwide COVID-19 public health emergency. At this time, the agency does not anticipate making any more determinations on additional AstraZeneca lots manufactured at the Emergent facility.
- On Feb. 17, the FDA warned consumers not to use certain powdered infant formula produced in Abbott Nutrition’s facility in Sturgis, Michigan. The FDA is investigating consumer complaints of Cronobacter sakazakii and Salmonella Newport infections, and all of the cases are reported to have consumed powdered infant formula produced from this Abbott facility. The FDA worked with the firm to initiate a voluntary recall of the potentially affected product, including Similac, Alimentum and EleCare powdered formulas manufactured in its Sturgis facility. Products made at this facility can be found across the U.S. and were likely exported to other countries as well. Canadian health officials have also issued a recall warning. Additional recall information is available on the FDA website. Parents can also enter their product lot code on the company’s website to check if it is part of the recall.
- On Feb. 17, the FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA. The 43 PSGs include 13 for complex products and new PSGs for medications to treat diseases such as COVID-19, spinal muscular atrophy, non-small cell lung cancer and prostate cancer.
- COVID-19 testing updates:
- As of today, 420 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 85 antibody and other immune response tests and 45 antigen tests. There are 70 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 15 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 26 antigen tests and 10 molecular tests for serial screening programs. The FDA has also authorized 835 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.
- FDA Office of Media Affairs