Health
FDA Roundup: July 2, 2024
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- FOR IMMEDIATE RELEASE:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news about the agency.
- Today, the FDA shelter Donanemab-AZBT injection for the treatment of Alzheimer's disease.
“Alzheimer's disease is a devastating illness for those diagnosed and their families,” said Theresa Bracchio, director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research. “Clinical trial data convincingly demonstrate that Kisunra reduces the rate of cognitive and functional decline in patients with mild cognitive impairment and mild dementia stages of Alzheimer's disease. Today's approval is a testament to the FDA's commitment to helping provide safer and more effective Alzheimer's treatments.”
- Today, the FDA: Regulation Authorizes the use of brominated vegetable oil (BVO) in food. Brominated Vegetable Oil (BVO) It is a vegetable oil that has been modified with bromine. After testing, authorities have concluded that BVO is unsafe for use in food. the study A study conducted in collaboration with the National Institutes of Health (NIH) found that the substance could have adverse effects on the human body. The rule goes into effect on August 2.
“It is a priority for the FDA to reevaluate the safety of chemicals approved for use in our food when new relevant data become available. We are committed to conducting reevaluations to ensure that our original safety determinations are maintained over time. Our removal of the only approved use of BVO from the food supply was based on a thorough review of the latest science and research findings that raised safety concerns. We will continue to monitor new evidence on chemicals we have subject to reevaluation and take action to protect the public health in cases such as this one where the science no longer supports continued approved uses,” said Jim Jones, Deputy Commissioner for Human Foods.
- On Monday, the FDA's Center for Devices and Radiological Health (CDRH) Announced Continued expansion of the Total Product Life Cycle Advisory Program, launched in 2023 as an effort under reauthorization of the Medical Device User Fee Amendments Act (MDUFA) V to foster more rapid development of high-quality, safe, effective, and innovative medical devices essential to meeting public health needs.
- On Friday, the FDA’s Center for Veterinary Medicine hosted two webinars for stakeholders interested in FDA regulations. Intentional genome modification in animalsThe webinar will focus on two guidance documents: Guidance for Industry #187A: “Intentional Heritable Genomic Modifications in Animals: A Risk-Based Approach” draft Guidance for Industry #187B, “Intentional Heritable Genomic Modifications in Animals: Approval Process” The webinars will provide historical background to the guidance and provide more detail on what it covers. These and other webinars will be available to the agency’s Animal Biotechnology Products Resource Center.
- On Friday, the F.D.A. Recommendation Disease Investigation Bulletin: Diamond Shruumz brand chocolate bars, cones and gummies (June 2024) updated with information about the Prophet Premium Blends, LLC recall. The recall began on June 27, 2024 for all flavors of the Diamond Shruumz brand.
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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 FDA is also responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, electronic products that give off radiation, and for regulating tobacco products.
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