Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals. On January 27, 2023, the FDA granted accelerated approval to…
Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced – Letter to Health Care Providers
March 1, 2023 The U.S. Food and Drug Administration (FDA) is alerting health care facilities and providers about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohelp system. The disposable part is the HLS Set Advanced that contains the oxygenator, heat exchanger, and integrated centrifugal pump. On February 13, 2023, Getinge/Maquet issued…
FDA D.I.S.C.O. Burst Edition: FDA approval of Trodelvy (sacituzumab govitecan-hziy) for HR-positive breast cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On February 3, 2023, the FDA approved sacituzumab govitecan-hziy (brand…
Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration- Letter to Health Care Providers
February 27, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which feature leaflets externally mounted to the valve frame. Information from published literature…
ACTUALIZACIÓN: Uso del Dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicado de seguridad de la FDA
English ACTUALIZACIÓN – 27 de febrero de 2023 – El 23 de febrero de 2023, la Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) autorizó el Renuvion APR Handpiece para la administración de energía de radiofrecuencia y/o plasma de helio donde se necesita la coagulación/contracción del tejido blando. El…
Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial Contamination
Summary Company Announcement Date: February 23, 2023 FDA Publish Date: February 24, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to possible microbial contamination Company Name: Global Pharma Healthcare Brand Name: Brand Name(s) Delsam Pharma’s Product Description: Product Description Artificial Eye Ointment Company Announcement FOR IMMEDIATE RELEASE – February 23, 2023, Global…
Evaluation of Airborne Chemicals from Neonatal Incubators – Letter to Health Care Providers
February 23, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers and facilities about the potential for exposure to airborne chemicals that may be released from neonatal incubators. The FDA is evaluating published literature that reports elevated levels of formaldehyde, cyclohexanone, and other volatile chemicals (such as human-made chemicals used and…
Milk and Plant-Based Milk Alternatives: Know the Nutrient Difference
Image Español The milk section of the dairy case isn’t what it used to be. Along with milk, there’s a growing variety of plant-based milk alternatives. While many plant-based milk alternatives have the word “milk” in their name, the nutritional content can vary between the products, and many of them don’t have the same amount…
nanoMaterials Discovery Corporation Issues Voluntary Nationwide Recall of its Alcohol Antiseptic 80% Alcohol Solution
Summary Company Announcement Date: February 14, 2023 FDA Publish Date: February 21, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to presence of methanol Company Name: nanoMaterials Discovery Corporation Brand Name: Brand Name(s) nanoMaterials Discovery Corporation Product Description: Product Description Hand Sanitizer Company Announcement FOR IMMEDIATE RELEASE – February 14, 2023 –…
Caution Consumers: Honey-based or Honey-flavored Syrup Products May Pose Health Risk
Image Español Don’t Fall for False Claims When you’re browsing, one of the best ways to protect yourself from fake, and even possibly harmful, products is asking whether a claim sounds too good to be true, or if it contradicts what you’ve heard from reputable sources. On July 12, 2022, the U.S. Food and Drug…