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FDA Roundup: May 24, 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:

  • On May 23, the FDA announced the availability of one final guidance and two draft guidances for blood establishments. The final guidance, “Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components,” removes the recommendations to defer indefinitely blood donors for: 1) geographic risk of possible exposure to bovine spongiform encephalopathy for time spent in the United Kingdom (U.K.) from 1980-1996 and for time spent in France and Ireland from 1980-2001, and 2) receipt of a blood transfusion in the U.K., France, and Ireland from 1980-present.  The guidance also provides recommendations for requalification of individuals previously deferred for these geographic risk factors, provided they meet all other eligibility requirements. 

    The draft guidance, “Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy,” describes the circumstances in which FDA does not intend to take regulatory action for a blood establishment’s failure to comply with certain regulations for determining the eligibility of blood donors with blood pressure or pulse outside the specified limits. The draft guidance, “Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements,” describes the conditions under which the FDA does not intend to take regulatory action for a blood establishment’s failure to comply with certain requirements regarding donation suitability, donor eligibility, and quarantine hold for Source Plasma. The draft guidance also describes proposed procedures for filing of annual reports on the release of unsuitable donations to the FDA by blood establishments. The FDA expects the recommendations in the guidances (including the draft guidances, when finalized) will increase the availability of blood and blood components, including Source Plasma, while maintaining the health of blood donors and the safety of blood and blood components.  

  • On May 23, the FDA announced the availability of a report drafted by the Reagan-Udall Foundation as part of a cooperative agreement. The report summarizes key findings from a series of targeted conversations with stakeholders about the feasibility of establishing a voluntary public-private partnership to collect and analyze antimicrobial use data from food-producing animals. The Foundation will host a virtual public forum on June 14, 2022, from 1:00 pm to 3:00 pm to present insights from the report and allow for questions from the public. The FDA has also opened a docket to accept public comments through August 21, 2022.
  • On May 17, the FDA authorized marketing of BONESUPPORT AB Cerament G, the first device-drug combination product of its kind. The product is a bone void filler (bone graft substitute) with the antibiotic gentamicin added. It is intended as an adjunct to systemic antibiotic therapy and surgical debridement as part of the surgical treatment of osteomyelitis. Osteomyelitis occurs when an infection develops in a bone or spreads to a bone from another area of the body. Risk factors for the osteomyelitis include diabetes, surgery involving the bones, poor blood supply, recent injury, intravenous drug abuse, or a weakened immune system.
  • COVID-19 testing updates:
    •  As of today, 435 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 302 molecular tests and sample collection devices, 83 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 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, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests. 
    • The FDA has authorized 27 antigen tests and 7 molecular tests for serial screening programs. The FDA has also authorized 982 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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