SILVER
SPRING, Md., Sept. 13,
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 published the FDA Voices: "Join FDA for
the First National Hispanic/Latino Family Cancer Awareness Week,
Sept. 20-26," by Luckson Mathieu, MD, Senior Clinical Reviewer,
DO2, OND; Donna Rivera, MD,
Associate Director for Pharmacoepidemiology, Oncology Center of
Excellence (OCE), and Rea Blakey,
Associate Director for External Outreach and Engagement, OCE.
Project Community within the FDA's OCE will hold the first National
Hispanic/Latino Family Cancer Awareness Week Sept. 20-26, 2024, to increase cancer awareness
within the Hispanic/Latino population. The week will feature a
virtual Conversation on Cancer public panel discussion and a social
media campaign using the hashtag #LatinoCancer.
- On Thursday, the FDA released a Drug Safety Communication
warning that Veozah (fezolinetant), a medicine used to treat hot
flashes due to menopause, can cause rare but serious liver injury.
Patients should stop taking Veozah immediately and seek medical
attention, including liver blood testing, if they experience signs
and symptoms that suggest liver problems such as feeling more tired
than usual; nausea; vomiting; unusual itching; light-colored
stools; yellowing of the eyes or skin, called jaundice; dark urine;
swelling in the stomach area, called the abdomen; or pain in the
right upper abdomen.
If you are taking Veozah or want to learn about whether Veozah may
be right for you, talk to your health care professional about the
risks and benefits of receiving Veozah and discuss any questions or
concerns you may have, including about possible alternative
treatments. For more information, please visit: FDA adds warning
about rare occurrence of serious liver injury with use of Veozah
(fezolinetant) for menopausal hot flashes.
- On Thursday, the FDA approved Tecentriq Hybreza (atezolizumab
and hyaluronidase-tqjs) for subcutaneous injection for all the
adult indications as the intravenous formulation of Tecentriq
(atezolizumab, Genentech, Inc.), including non-small cell lung
cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular
carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS).
Full prescribing information for Tecentriq Hybreza will be posted
on Drugs@FDA.
- On Wednesday, the FDA announced recognition of additional
consensus standards to advance innovation in medical device
sterilization processes: ISO 11737-3:2023 Microbiological methods,
ISO 11140-1:2014 Chemical indicators, and ISO 13004:2022 Radiation
- Substantiation of selected sterilization dose. By promoting the
techniques in these international standards, the FDA is
facilitating the adoption of sterilization of medical devices,
enhancing quality, and advancing international harmonization.
- On Tuesday, the FDA posted a new video in the "FDA In Your Day"
series. In this video, Chief Medical Officer, Dr. Hilary Marston discusses FDA's cinnamon-related
actions.
- On Tuesday, the FDA announced that the final rule to the
updated mammography regulations that were issued under the
Mammography Quality Standards Act (MQSA) went into effect that day,
September 10, 2024. The final rule
established federal standards designed to categorize breast tissue
density, enhance communication to patients, and raise the bar for
accreditation and facilities, among others. The MQSA and its
implementing regulations do not include clinical practice
guidelines. The interpretation of the imaging findings remains the
responsibility of the qualified interpreting physician.
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