SILVER
SPRING, Md., April 19,
2024 /PRNewswire/ -- Today, the U.S. Food and Drug
Administration is providing an at-a-glance summary of news from
around the agency:
- On Thursday, the FDA posted a safety communication to inform
the public and healthcare providers that the agency has required
and approved labeling changes to the U.S. Prescribing Information
(USPI) for all licensed BCMA-directed and CD19-directed genetically
modified autologous CAR-T cell immunotherapies.
These completed changes follow a safety communication posted by the
FDA in November 2023, and reflect
requirements detailed in notification letters issued by the FDA in
January 2024, to all manufacturers of
the products in this class necessitating an update to the Boxed
Warning on the package insert to include new safety information on
the serious risk of T cell malignancies, with serious outcomes,
including hospitalization and death. The FDA also required related
safety labeling changes to other sections of the USPI: Warnings and
Precautions, Postmarketing Experience, Patient Counseling
Information and Medication Guide.
- On Thursday, the FDA approved alectinib (Alecensa, Genentech,
Inc.) for adjuvant treatment following tumor resection in patients
with anaplastic lymphoma kinase (ALK)-positive non-small cell lung
cancer (NSCLC), as detected by an FDA-approved test. Full
prescribing information for Alecensa will be posted here.
- On Thursday, the FDA shared updates on agency activities to
better understand Per- and Polyfluoroalkyl Substances (PFAS) in the
food supply, including testing results, continuing efforts to
supplement our PFAS monitoring, and an updated analytical method to
measure PFAS.
- On Wednesday, the FDA's Center for Devices and Radiological
Health Center (CDRH) released two reports on medical device safety
and innovation –core pillars that help protect and promote public
health for all. The "CDRH 2024 Safety Report" and the "CDRH 2024
Innovation Report" provide summaries of CDRH's accomplishments and
look ahead to future initiatives.
"Our focus on safety and innovation stems from our vision to
protect and promote the public health by helping to assure that
medical devices on the U.S. market are high-quality, safe and
effective, and that patients and providers have timely and
continued access to these devices," said CDRH Director Dr.
Jeff Shuren.
- On Wednesday, the FDA issued an outbreak advisory for a
multistate outbreak of Salmonella Typhimurium infections
linked to Infinite Herbs-brand organic basil packed in 2.5-oz
clamshell packaging and sold at Trader Joe's stores in AL, CT,
D.C., DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC,
NE, NH, NJ, NY, OH, PA, RI, SC, TN, VA, VT, and WI. Typhimurium
infections linked to Infinite Herbs-brand organic basil packed in
2.5-oz clamshell packaging and sold at Trader Joe's stores in AL,
CT, D.C., DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO,
NC, NE, NH, NJ, NY, OH, PA, RI, SC, TN, VA, VT, and WI.
- On Wednesday, the FDA approved Lumicell Inc.'s Direct
Visualization System, a combination product that is the first
fluorescent imaging system to assist in the detection of cancerous
tissue within the lumpectomy cavity following the removal of the
primary specimen during breast conserving surgery. This product
consists of an optical imaging agent Lumisight (the drug
pegulicianine) that is administered to the patient via intravenous
injection two to six hours before imaging and a fluorescence
imaging system designed to capture emissions from the optical
imaging agent.
- On Wednesday, the FDA also approved Lumisight (pegulicianine)
in adults with breast cancer to assist the intraoperative detection
of cancerous tissue within the resection cavity following removal
of the primary specimen during lumpectomy surgery. Lumisight is a
fluorescent imaging drug for use with the Lumicell Inc.'s Direct
Visualization System that is administered in the form of an
intravenous injection before surgery.
- On Tuesday, Nature Medicine published a new commentary
co-authored by the FDA's Center for Tobacco Products Director
Brian King, Ph.D., M.P.H.,
discussing considerations for healthcare providers around talking
to adults about the relative risks of different tobacco products.
The commentary reinforces that youth should not use any form of
tobacco products. Among adults who smoke, it stresses the
importance of using evidence-based cessation methods, including
FDA-approved pharmacotherapies, as a first line treatment. For
adults who smoke and have tried proven cessation methods with no
success, medical providers may consider educating patients about
the relative risks of tobacco products and the importance of
switching completely to a lower-risk product in order to realize
the full health benefit, and of not engaging in prolonged use of
both products. In conjunction with this release, the FDA launched a
new webpage aimed at educating the public about the relative risks
of tobacco products.
- On Tuesday, the FDA launched a new post-incident response web
page about elevated lead levels in cinnamon, focused on
post-incident surveillance, prevention, and compliance
activities.
- On Monday, the FDA issued marketing denial orders (MDOs) to
Shenzhen Yibo Technology Co. Ltd. for 65 disposable e-cigarettes
marketed as "MNGO Disposable Stick." As a result, the company must
not market or distribute these products in the United States or they risk FDA enforcement
action.
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