FDA Roundup: April 23, 2024

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Apr 23, 2024, 16:02 ET

SILVER SPRING, Md., April 23, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Today, the FDA announced a new initiative aimed to help reimagine the home environment as an integral part of the health care system. The Home as a Health Care Hub is intended to enable solutions that seamlessly integrate medical devices and health care, prevention and wellness into people's lives and may:
- Help medical device developers consider novel design approaches.
- Aid providers to consider opportunities to extend care options and educate patients.
- Generate discussions on value-based care paradigms.
- Open opportunities to bring clinical trials and other evidence generation processes to underrepresented communities.

This new initiative is part of the FDA's ongoing commitment to advancing health equity and helping people to 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 Home as a Health Care Hub and we will keep the public informed as additional information becomes available.

Today, the FDA published the FDA Voices: "Reflections on Travel to Europe – Part Three," by Robert M. Califf, M.D., Commissioner of Food and Drugs. In this final of a three-part series of blogs, Dr. Califf provides his perspective on his recent trip to the Europe Union and describes key events and issues. The team's official travel took them for visits with the U.S. Mission to the European Union (EU) in Brussels; Ambassador Gitenstein, the U.S. Ambassador to the EU; the European Food Safety Authority; the European Commission and the Directorate-General SANTE; and the European Medicines Agency.
On Monday, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Guérin (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 posted here.
On Monday the FDA published the FDA Voices: "Reflections on Travel to Europe – Part Two," by Robert M. Califf, M.D., Commissioner of Food and Drugs. In this part two of a three-part series of blogs, Dr. Califf provides his perspective on his recent trip to Europe and describes key events and issues. The team's official travel took them to the U.K. for an initial dinner with an eclectic group from the U.K. dealing with policies ranging from women's health and diversity in clinical trials to the impact of the medical products industry on the economy to pandemic preparedness and response. The team visited interesting and historical venues, like the Royal Academy of Medicine, for a meeting with the Medicines and Healthcare products Regulatory Agency and closed with a trip to Oxford to engage with the academic clinical trials community.
On Monday, the FDA approved Rezenopy, a 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 to relieve the airway obstruction in choking victims. These protocols include abdominal thrusts (also called the "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 FDA approved or cleared. 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 for a multistate outbreak of Salmonella Typhimurium infections linked fresh organic basil to include Infinite Herbs, LLC, recall and expanded recall. On 4/18/2024, the firm voluntarily recalled 2.5-oz packages of Infinite Herbs-brand fresh organic basil sold at Trader Joe's and Fruit Center Marketplace stores from February 1 through April 6, 2024. On April 19, 2024, the recall was expanded to include 2.0- and 4.0-oz packages of Melissa's-brand organic basil available for sale at Dierberg's stores in Illinois and Missouri from February 10 through February 20, 2024.

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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.

SOURCE U.S. Food and Drug Administration