FDA Roundup: September 13, 2024

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.

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