FDA Roundup: August 23, 2022

August 24, 2022

For Instant Launch:

Immediately, the U.S. Meals and Drug Administration is offering an at-a-glance abstract of reports from across the company:  

  • Immediately, the FDA’s Workplace of World Coverage and Technique posted an article concerning the FDA’s fruitful partnership with the Inter-American Institute for Cooperation in Agriculture or IICA — an company working to advance agricultural improvement and rural well-being throughout the Americas. IICA helps to facilitate the implementation of the FDA’s Meals Security Modernization Act necessities in Latin America. 
  • On August 22, the FDA and the Duke-Margolis Heart for Well being Coverage introduced a digital public workshop on October 11 titled, “Challenges and Alternatives for REMS Integration, Innovation, and Modernization.” The workshop will solicit suggestions from key stakeholders on a Danger Analysis and Mitigation Methods (REMS) integration prototype. Audio system from FDA and MITRE will lead the workshop with sufferers, prescribers, pharmacists, well being system representatives, informaticists, and different key stakeholders collaborating in a collection of moderated panel discussions specializing in how the prototype can tackle challenges related to integrating REMS necessities into scientific workflows to facilitate protected remedy use.
  • COVID-19 testing updates:  
    • As of as we speak, 439 exams and pattern assortment gadgets are approved by the FDA below emergency use authorizations (EUAs). These embrace 302 molecular exams and pattern assortment gadgets, 85 antibody and different immune response exams, 51 antigen exams, and 1 diagnostic breath take a look at. There are 78 molecular authorizations and 1 antibody authorization that can be utilized with home-collected samples. There may be 1 EUA for a molecular prescription at-home take a look at, 2 EUAs for antigen prescription at-home exams, 19 EUAs for antigen over-the-counter (OTC) at-home exams, and three for molecular OTC at-home exams.
    • The FDA has approved 31 antigen exams and eight molecular exams for serial screening packages. The FDA has additionally approved 1091 revisions to EUA authorizations
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The FDA, an company inside the U.S. Division of Well being and Human Companies, protects the general public well being by assuring the security, effectiveness, and safety of human and veterinary medication, vaccines and different organic merchandise for human use, and medical gadgets. The company is also answerable for the security and safety of our nation’s meals provide, cosmetics, dietary dietary supplements, merchandise that give off digital radiation, and for regulating tobacco merchandise.