FDA Summary: July 8, 2022


For immediate release:

Today, the U.S. Food and Drug Administration provides an at-a-glance summary of news from the agency:

  • Today, the FDA approved COMIRNATY (COVID-19 vaccine, mRNA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2) in people aged 12 to 15 years. . The approval follows rigorous analysis and evaluation of safety and efficacy data conducted by the FDA. The Pfizer-BioNTech COVID-19 vaccine has been and will continue to be licensed for emergency use in this age group since May 2021. COMIRNATY (COVID-19 vaccine, mRNA) has been approved for use in people under 16 years and older since August 2021.
  • On Wednesday, the FDA finalized Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Animal Foods to assist animal food establishments undergoing FDA Food Safety Modernization Act (FSMA) Risk Analysis and Risk-Based Controls Requirements for Preventive Feed Controls develop a food safety plan to prevent or significantly reduce hazards that could cause illness or injury to people or animals .
  • The FDA will continue to host virtual town halls for SARS-CoV-2 test developers on July 27 and August 24 from 12:05 p.m. to 1 p.m. ET. Registration is not compulsory. During the virtual town hall, the FDA will share information and answer questions about the development and validation of tests for SARS-CoV-2. Recordings and transcripts will be available online for viewing after the live event.
  • COVID-19 testing updates:
    • To date, 438 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 303 molecular tests and sample collection devices, 85 antibody tests and other immune response tests, 49 antigen tests and 1 diagnostic breath test. There are 80 molecular clearances and 1 antibody clearance that can be used with home samples. There is 1 EUA for molecular prescription home testing, 2 EUA for antigen prescription home testing, 17 EUA for over-the-counter (OTC) antigen home testing and 3 for home testing Molecular OTCs.
    • The FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA also authorized 1021 revisions to EUA clearances.

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.


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