October 25, 2024 - FDA Roundup: October 25, 2024

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

• Today, the FDA updated the advisory for the outbreak of E. coli O157:H7. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald's Quarter Pounder burgers. Investigators are working to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination. McDonald's has temporarily stopped using Quarter Pounder slivered onions and beef patties in affected states. Diced onions and other types of beef patties used at McDonald's have not been implicated in this outbreak. Additionally, Taylor Farms has initiated a voluntary recall of some onions sent to food service customers. Customers who are impacted have been contacted directly. As of Oct. 24, 75 people infected with the outbreak strain of E. coli O157:H7 have been reported from 13 states. Illnesses started on dates ranging from Sept. 27, 2024, to Oct. 10, 2024. Of 61 people with information available, 22 have been hospitalized and two people developed hemolytic uremic syndrome, a serious condition that can cause kidney failure. One death has been reported from an older adult in Colorado. Of the 42 people interviewed, all 42 (100%) report eating at McDonald's and 39 people report eating a beef hamburger. Consumers who have already eaten at McDonald's and have symptoms of E. coli infection should contact their health care provider to report their symptoms and receive care immediately. The FDA is working closely with the U.S. Department of Agriculture, the Food Safety and Inspection Service, the Centers for Disease Control and Prevention and state partners to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination. Additional information will be published in the advisory as it becomes available.
• On Thursday, the FDA issued guidance to help tattoo ink manufacturers and distributors recognize situations in which tattoo ink may become contaminated with microorganisms. The guidance titled "Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination" contains recommendations that include: testing ink and ink components for possible microbial contamination; ensuring the manufacturing process does not introduce microbial contamination; ensuring appropriate sterilization methods are used, when applicable; and taking corrective measures to prevent the release of any product containing microbial contamination.
• On Wednesday, the FDA announced the virtual Medical Device Sterilization Town Hall - Sterilization Short Topics and Open Q&A that will be held on Oct. 30, 2024, from 1-2:30 p.m. ET. During this town hall, the FDA will discuss submitted questions and comments, activities to support medical device innovators and bundling sterility submissions. We will also host an open question-and-answer session. Registration is not necessary. We encourage attendees to submit questions to [email protected] by 4 p.m. ET on Friday, Oct. 25, 2024.
• On Wednesday, the FDA finalized Guidance for Industry (GFI) #293: FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients. Draft GFI #294: Animal Food Ingredient Consultation (AFIC) has not yet been finalized but the agency will notify the public when final guidance is issued. The FDA will continue to accept comments submitted to docket FDA-2024-N-2979 in response to the Request for Comments on the FDA's premarket animal food review processes until Dec. 9, 2024.
• On Wednesday, the FDA published a Consumer Update, FDA's Critical Role in Ensuring Safe and Effective Flu Vaccines, reminding the public that the flu vaccine received at a doctor's office or pharmacy is the result of year-round work of highly skilled microbiologists, epidemiologists, physicians and other public health experts. As new strains of flu viruses emerge, the FDA closely coordinates with sister agencies and works with manufacturers to help the development of vaccines to protect from the flu. All FDA-approved flu vaccines are safe and effective.
• On Tuesday, the FDA announced that Michelle Tarver, M.D., Ph.D., has been selected as the permanent director of the FDA's Center for Devices and Radiological Health (CDRH). Dr. Tarver is a board-certified ophthalmologist with a doctorate in epidemiology and has held various leadership positions at the FDA as a medical device regulator, helping drive strategic initiatives, conduct clinical research and changing organizational culture. Under her leadership, CDRH launched numerous efforts to amplify the perspectives of people living with medical conditions, foster collaboration across the health care ecosystem and stimulate creative evidence generation pathways.
  
  "I am truly honored to lead CDRH and our talented staff across the Center who are committed to protecting and promoting public health," said Michelle Tarver, M.D., Ph.D., director of the FDA's CDRH. "As someone who has served the FDA for more than 15 years, I am immensely proud of the work we have accomplished together, always keeping the people we serve at the core of our mission. As we embark on CDRH's next chapter, we remain committed in our service to public health and ensuring all patients in the U.S. have access to high-quality, safe and effective medical devices."
• On Tuesday, the FDA announced a new dataset generated in a clinical study that assessed the way people with Parkinson's disease move over time compared with those who don't have the disease. Researchers used wearable sensors and video cameras to gather data about study participants' gait. The result is an open access dataset that can be used to assess the performance of algorithms used in wearable sensors and identify and validate digital biomarkers relevant to people with Parkinson's disease. The use of this regulatory science tool may help to accelerate the development and evaluation of novel medical devices in this important area. The dataset is the result of a partnership between the FDA, VA Ventures and the Johns Hopkins University School of Medicine.
• On Tuesday, the FDA approved the vaccine Abrysvo for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Since 2023, Abrysvo has been approved for the prevention of LRTD caused by RSV in individuals 60 years of age and older and for use in pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through six months of age. Abrysvo is manufactured by Pfizer Inc.

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