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  5. FDA Roundup: September 16, 2022
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FDA News Release

FDA Roundup: September 16, 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 Wednesday, the FDA announced that it is taking steps to help increase the availability of novel treatments for rare diseases and conditions in dogs and cats. When a new animal drug is intended to treat a disease or condition (1) in a major species, (2) that occurs infrequently or in limited geographic areas, and (3) in less than a “small number” of animals annually, then that drug meets the definition of “minor use.” Drugs that meet the definition of “minor use” are eligible for Minor Use/Minor Species (MUMS) Designation, Conditional Approval, waivers from user fees, and are also eligible to receive exclusive marketing rights and grants to support product development and approval. 
  • On Wednesday, the FDA Office of Regulatory Affairs (ORA) officially launched ORA News and Stories, a new, public-facing platform on FDA.gov. Announced as part of National Food Safety Education Month, the site features the news, conversations, media coverage and unique stories of what ORA does on the frontlines of public health. This month’s feature article, Scrutiny and Safety at Toyosu Market, follows Consumer Safety Officer Derek Dealy as he performs an investigation at the largest wholesale fish market in the world. Another article highlights the work of microbiologist Nancy Miranda, who shares how she and her colleagues in the labs are tracking down pathogens, such as Cronobacter sakazakii, in infant formulas. ORA News and Stories will also showcase the latest ORA innovations and enterprising ideas in the everyday work to protect Americans.
  • On Thursday, the FDA warned consumers about social media trends encouraging people to misuse nonprescription medications. These video challenges, which often target youth, can harm people — and even cause death. Nonprescription (also called over-the-counter, or OTC) drugs are readily available in many homes, making these challenges even more risky. OTC drugs can pose significant risks if they’re misused or abused.
  • On Thursday, the FDA announced a virtual meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to be held on Nov. 1, 2022, from 9 a.m. to 6 p.m. ET. The committee will discuss ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations. The committee will also discuss factors that may affect pulse oximeter accuracy and performance, the available evidence about the accuracy of pulse oximeters, recommendations for patients and health care providers and the amount and type of data that should be provided by manufacturers to assess pulse oximeter accuracy and to guide other regulatory actions as needed.
  • COVID-19 testing updates:
    • As of today, 438 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 301 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 79 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1114 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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