For immediate release:

Today, the US Food and Drug Administration provides a quick overview of news from around the agency.

  • Today, the FDA announced that it has discovered that an additional four lots of AstraZeneca COVID-19 vaccine drug substance manufactured at an emergency facility in Baltimore, Maryland can be used for potential exports. AstraZeneca vaccines are not licensed for use in the United States, but the FDA has stated that these AstraZeneca lots, or vaccines made from these lots, may now be exported for use. I understand. Authorities thoroughly review facility records and the results of quality tests conducted by the manufacturer and make decisions based on this review, taking into account the current global COVID-19 public health emergency. did. At this time, the agency does not expect to make any further decisions regarding additional AstraZeneca lots manufactured at the Emergency facility.
  • February 17, FDA warned consumers Do not use certain powdered milk produced at the Abbott Nutrition facility in Sturgis, Michigan. The FDA is investigating consumer complaints of Cronobacter Sakazaki and Salmonella Newport infections and reportedly consumed powdered milk produced from this Abbott facility in all cases. FDA working with the company Voluntary collection Products manufactured at this facility, such as Similac, Alimentum, and EleCare milk powders manufactured at the Sturges facility, may be found throughout the United States and exported to other countries. There is sex.Canadian health authorities Remember the warning.. Additional recall information FDA website..Parents can also enter the product lot code in Company website Check if it is part of the recall.
  • On February 17, the FDA released the next new batch Product-specific guidance (PSG). PSG provides recommendations for developing generic drugs and generating the evidence needed to support simplified New Drug Application (ANDA) approval. This will help the industry develop generic drugs and streamline ANDA assessments by the FDA. The 43 PSGs include 13 PSGs for complex products and new PSGs for pharmaceuticals to treat diseases such as COVID-19, spinal muscular atrophy, non-small cell lung cancer, and prostate cancer. increase.
  • COVID-19 test update:
    • As of today, 420 test and sample collection devices have been approved by the FDA under an Emergency Use Authorization (EUA). These include 290 molecular and sample collection devices, 85 antibody and other immune response tests, and 45 antigen tests. There are 70 molecular certifications and one antibody certification that can be used with homemade samples. There is one EUA for molecular prescription home inspection, three EUA for antigen prescription home inspection, 15 EUA for antigen over-the-counter (OTC) home inspection, and three EUA for molecular OTC home inspection.
    • The FDA has approved 26 antigen tests and 10 molecular tests for a continuous screening program. The FDA has also approved 835 amendments to EUA approval.

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An agency within the U.S. Department of Health and Human Services, the FDA by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines, and other human-used biological products and medical devices. We protect public health. Authorities are also responsible for the safety and security of our food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.