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FDA Roundup: January 21, 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 announced two FY 2022 funding opportunities that could provide up to $800,000 in support of antimicrobial stewardship in veterinary settings and reducing antimicrobial resistance in animal agriculture. The first grant program is aimed at identifying potential alternative practices for reducing reliance on antimicrobial drugs for addressing the health needs of food-producing animals. The second grant program is focused on developing educational strategies for disseminating information on antimicrobial resistance and on implementing antimicrobial stewardship practices in food-producing animals.
  • Today, the FDA released the FDA Voices: What FDA’s Foods Program Achieved in 2021 to Protect Consumers and the Food Supply, bylined by Frank Yiannas, Deputy Commissioner for Food Policy and Response.
  • On Jan. 20, the FDA announced the approval of Zorbium (buprenorphine transdermal solution), the first transdermal buprenorphine animal drug intended to control pain in cats after surgery. Because Zorbium is a long-acting solution applied in the veterinary hospital, it may eliminate or reduce the need for cat owners to administer additional pain medications. It also provides veterinarians an additional option for controlling postoperative pain in cats.
  • On Jan. 19, the FDA updated the device shortage list to include all blood specimen collection tubes (product codes GIM and JKA) to the testing supplies and equipment – specimen collection category on the device shortage list. The list previously included sodium citrate (light blue top) tubes only. The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time. The FDA will continue to update the list as the COVID-19 public health emergency evolves. Read More.
  • On Jan. 18, the FDA extended the previously announced temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant. 
    The agency continues to conduct both foreign and domestic mission-critical inspections, as well as provide effective oversight of foods, drugs, medical products and tobacco leveraging a variety of tools, including remote assessments and import operations surveillance. 
    The FDA is extending the pause on domestic surveillance inspections through Feb. 4 with the goal of restarting these activities as soon as safely possible. The agency will proceed with previously planned foreign surveillance inspections that have received country clearance and are within the CDC’s Level 1 or Level 2 COVID-19 travel recommendation; otherwise, the inspection will be rescheduled. The FDA’s goal is to return to a regular cadence for foreign surveillance inspections in April. 
    The agency also is continuing remote foreign supplier verification program activities for human and animal foods. Additionally, state inspections under FDA contract and cooperative agreements have the discretion to make inspection decisions based on their local information.
  • COVID-19 testing updates:
    • As of today, 422 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests and 45 antigen tests. There are 69 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, 14 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests. 
    • The FDA has authorized 25 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 774 revisions to EUA authorizations.

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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.


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