For immediate release:

Today, the U.S. Food and Drug Administration provides an at-a-glance summary of news from the agency:

  • Today, the FDA announced a new initiative to reinvent the home environment as an integral part of the health care system. THE The home as a health care center is intended to enable solutions that seamlessly integrate medical devices and healthcare, prevention and well-being into people's lives and can:
    • Help medical device developers consider new design approaches.
    • Support providers should consider opportunities to expand care options and educate patients.
    • Generate discussions about value-based care paradigms.
    • Open opportunities to bring clinical trials and other evidence generation processes to underrepresented communities.

    This new initiative is part of FDA's ongoing commitment to advancing health equity and helping people get the care they need, when they need it. The FDA is collaborating with patient groups, health care providers, the medical device industry and housing experts to build the The home as a health care center and we will keep the public informed as additional information becomes available.

  • Today, FDA released FDA Voices: Reflections on Travel to Europe Part Three, authored by Robert M. Califf, MD, Commissioner of Food and Drugs. In this latest in a series of three blogs, Dr Califf gives his views on his recent trip to the European Union and describes key events and issues. The team's official trip took them to visit the U.S. Mission to the European Union (EU) in Brussels; Ambassador Gitenstein, US Ambassador to the EU; the European Food Safety Authority; the European Commission and the Directorate General HEALTH; and the European Medicines Agency.
  • On Monday, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Gurin (BCG) for adult patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). with or without papillary tumors. Full prescribing information for Anktiva will be released here.
  • On Monday, the FDA released FDA Voices: Reflections on Travel to Europe Part Two, authored by Robert M. Califf, MD, Commissioner of Food and Drugs. In this second part of a three-part blog series, Dr. Califf gives his perspective on his recent trip to Europe and describes key events and issues. The team's official trip took them to the United Kingdom for a first dinner with an eclectic group from the United Kingdom covering policies ranging from women's health and diversity in clinical trials to the impact of medical products industry on the economy, including pandemic preparedness and response. The team visited interesting and historic locations, such as the Royal Academy of Medicine, for a meeting with the Medicines and Healthcare products Regulatory Agency and finished with a trip to Oxford to engage with the academic testing community clinics.
  • On Monday, the FDA approved Rezenopiaa 10-milligram naloxone hydrochloride intranasal spray indicated to treat opioid overdose.
  • On Monday, the FDA issued a safety communication to encourage the public to follow established anti-choking protocols, which are step-by-step guides approved by the American Red Cross and the American Heart Association for relieving obstructed breathing. respiratory tract in victims of choking. These protocols include abdominal thrusts (also called Heimlich maneuver) for children and adults. These protocols do not include anti-choking devices. The safety and effectiveness of over-the-counter anti-choking devices have not been established; they are not approved or cleared by the FDA. If you choose to use them, only use anti-choking devices after established choking protocols have failed.
  • On Friday, the FDA updated an outbreak advisory regarding a multistate outbreak of Salmonella Typhimurium infections linked to fresh organic basil to include the Infinite Herbs, LLC recall and expanded recall. On 04/18/2024, the company voluntarily recalled 2.5 ounce packages of Infinite Herbs brand fresh organic basil sold in Trader Joes and Fruit Center Marketplace stores from February 1 to April 6, 2024. April 19, 2024 , the recall has been expanded to include 2.0 and 4.0 ounce packages of Melissas brand organic basil available for sale at Dierberg stores in Illinois and Missouri from February 10-20, 2024.

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The FDA, an agency of the U.S. Department of Health and Human Services, protects the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, as well as medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and the regulation of tobacco products.