SILVER
SPRING, Md., April 30,
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, in coordination with the U.S. Department of
Justice (DOJ), announced that the U.S. Marshals Service seized
unauthorized e-cigarette products valued at more than $700,000. The e-cigarettes were located in a
warehouse in Alhambra, CA, and are
believed to be owned by several California-based distributors. The seized
products were mostly flavored, disposable e-cigarette products,
including youth-appealing brands such as Puff Bar/Puff, Elf Bar/EB
Design, Esco Bar, Kuz, Smok, and
Pixi.
- On Monday, the FDA authorized marketing of Sensonics, Inc.'s
Eversense AP CGM System that includes a fully implantable sensor
with an anti-inflammatory drug (dexamethasone acetate) that is
slowly released onto the skin to reduce inflammation at the sensor
insertion site. This authorization creates a new pathway for
integrated continuous glucose monitoring (iCGM) systems that are
combination products to come to market. The Eversense AP CGM System
is intended to replace fingerstick blood glucose measurements for
diabetes treatment decisions, provide real-time glucose reading,
glucose trend information, and alerts for episodes of low or high
blood glucose levels (hypo and hyperglycemia). Adverse events
reported in the study included local infection, skin irritation and
pain or discomfort. This prescription-only system is intended for
people with diabetes 18 years of age and older and can be used
alone or in conjunction with digitally connected medical devices,
including automated insulin dosing systems.
- On Monday, the FDA granted traditional approval to tisotumab
vedotin-tftv (Tivdak, Seagen Inc. [now a part of Pfizer Inc.]) for
recurrent or metastatic cervical cancer with disease progression on
or after chemotherapy. Tisotumab vedotin-tftv previously received
accelerated approval for this indication. The most common adverse
reactions (≥25%), including laboratory abnormalities, were
decreased hemoglobin, peripheral neuropathy, conjunctival adverse
reactions, increased aspartate aminotransferase, nausea, increased
alanine aminotransferase, fatigue, decreased sodium, epistaxis, and
constipation. Full prescribing information for Tivdak will be
posted here.
- On Monday, the FDA announced it will host a listening session
on June 13, 2024 as part of its
broader work to optimize the use of, and processes for, advisory
committees. This virtual public meeting will focus on the
composition of advisory committees, ways to improve the experience
for members serving on committees and ways to ensure public
awareness and understanding of the role of the FDA advisory
committees. For more information and to register, please visit
Public Meeting: Optimizing FDA's Use of and Processes for Advisory
Committees - 06/13/2024 | FDA.
- On Monday, the FDA published the Advisory Committees Give FDA
Critical Advice and the Public a Voice Consumer Update to help
people better understand how the FDA relies on advisory committees
to help make sound decisions based on the best science available.
Advisory committees give FDA experts outside, independent, and
professional advice on various complex scientific, technical, and
policy issues.
- On Friday, the FDA announced it had made a risk-based decision
based on its review of safety and quality data and information and
does not expect the developer of PrecisePRP Canine (canine
leucoreduced allogeneic pooled freeze-dried platelet-rich plasma)
to submit an application for approval prior to marketing.
PrecisePRP Canine provides a species-specific source of
concentrated platelets in plasma for injection directly into a
dog's joint (intra-articular injection) and is the first animal
cell, tissue, and cell- and tissue-based product (ACTP) intended
for intra-articular use to undergo FDA review and receive this
determination.
- On Friday, the FDA approved Abbot Medical's Espirt BTK
Everolimus Eluting Resorbable Scaffold System, a first-of-a-kind
Breakthrough device to treat patients with chronic limb-threatening
ischemia (CLTI). A severe form of Peripheral Artery Disease, CLTI
is a result of a collection of fatty substances and calcification
that form plaque along the lining of the arteries and is associated
with pain, unhealing wounds and amputation of the lower leg and
foot and increased mortality. The Esprit BTK system is mounted on a
catheter and delivered to the lower leg to open narrowed arteries
with the intention of restoring blood flow while delivering an
anti-proliferative drug to keep the vessel from re-narrowing. The
device is contraindicated for use in patients with allergy or
hypersensitivity to device materials or with certain
anticoagulation or antiplatelet regimens.
- On Friday, the FDA posted a new video in the "FDA In Your Day"
series. In this video, Principal Deputy Commissioner Dr. Namandjé
Bumpus discusses Drug Takeback Day, National Minority Health Month,
and counterfeit Botox.
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