SILVER
SPRING, Md., July 2, 2024
/PRNewswire/ -- Today, the U.S. Food and Drug
Administration is providing an at-a-glance summary of news from
around the agency:
- Today, the FDA approved Kisunla (donanemab-azbt) injection
for the treatment of Alzheimer's disease.
"Alzheimer's disease is a devastating disease for the person
diagnosed and their loved ones," said Teresa Buracchio, director of the Office of
Neuroscience in the FDA's Center for Drug Evaluation and Research.
"The trial data demonstrated, convincingly, that Kisunla reduces
the rate of cognitive and functional decline in patients in the
mild cognitive impairment and mild dementia stages of Alzheimer's
disease. Today's approval is evidence of the FDA's commitment to
helping more safe and effective drugs to treat Alzheimer's disease
become available."
- Today, the FDA announced it is revoking
the regulation authorizing the use of brominated
vegetable oil (BVO) in food. Brominated vegetable oil (BVO) is a
vegetable oil that is modified with bromine. The agency concluded
that the intended use of BVO in food is no longer considered safe
after the results of studies conducted in collaboration with
the National Institutes of Health (NIH) found the potential for
adverse health effects in humans. The rule is effective
Aug. 2.
"Reassessing the safety of chemicals that have been previously
authorized for use in or with foods, as new, relevant data become
available, is a priority for the FDA. We are committed to
conducting reassessments to ensure that our original determinations
of safety have held up over time. The removal of the only
authorized use of BVO from the food supply was based on a thorough
review of current science and research findings that raised safety
concerns. We will continue to monitor emerging evidence on the
chemicals we have targeted for reassessment, and in cases such as
this, where the science no longer supports continued authorized
use, we will take action to protect public health," says
Jim Jones, Deputy Commissioner for
Human Foods.
- On Monday, the FDA's Center for Devices and Radiological Health
(CDRH) announced the continued expansion of the Total Product Life
Cycle Advisory Program, which was launched in 2023 as a commitment
under the Medical Device User Fee Amendments (MDUFA) V
reauthorization to help spur faster development of high-quality,
safe, effective, and innovative medical devices that are critical
to meeting public health needs.
- On Friday, the FDA's Center for Veterinary Medicine made
available two webinars for stakeholders interested in FDA
regulation of intentional genomic alterations in animals. The
webinars focus on two guidance documents: final Guidance for
Industry #187A, "Heritable Intentional Genomic Alterations in
Animals: Risk-Based Approach," and draft Guidance for Industry
#187B, "Heritable Intentional Genomic Alterations in Animals: The
Approval Process." The webinars provide historical background on
the guidances and walk through the details of what they cover.
These and other webinars are available in the agency's Animal
Biotechnology Products Resource Center.
- On Friday, the FDA updated the advisory for the
Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars,
Cones, & Gummies (June 2024) to
include information about the Prophet Premium Blends, LLC, recall.
The recall was initiated on 6/27/2024
for of all flavors of Diamond Shruumz-brand products.
Additional Resources:
Media Contact: FDA Office of Media Affairs,
301-796-4540
Consumer Inquiries: 888-INFO-FDA
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, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration