FDA Roundup: June 6, 2023

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Jun 06, 2023, 15:43 ET

SILVER SPRING, Md., June 6, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

On Monday, the FDA issued a Letter to Health Care Providers recommending health care facilities and health care providers implement conservation strategies for non-sterile, single-use pneumatic tourniquet cuffs in the United States. To this end, the FDA is providing a list of best practices and instructions for cleaning and sterilization/disinfection of these devices as well as recommending the use of alternative devices while the localized supply constraints last. These devices are mainly used in elective limb surgeries and in emergency and trauma settings.
On Friday, the FDA approved Advanced Medical Solutions Limited's LIQUIFIX Hernia Mesh Fixation (HMF) Devices, which include the FIX8 Laparoscopic HMF Device and Precision Open HMF Device. Comprised of an adhesive preloaded into a single-use, handheld applicator, these HMF devices are intended for the fixation of prosthetic polypropylene or polyester mesh in laparoscopic and open surgical repair of femoral and inguinal hernias. The HMF Devices includes a first-of-its-kind use of an acrylic glue to secure the mesh.
On Friday, the FDA authorized marketing of Tristel Solutions Limited's Duo UL, a high-level disinfectant foam for reprocessing ultrasound probes. Intended for use by qualified healthcare personnel, the foam contains chlorine dioxide and is manually spread on the probes for a required two-minute contact time.
On Friday, June 9^th, the Peripheral and Central Nervous System Drugs Advisory Committee will meet virtually to discuss the confirmatory study for the supplemental biologics license application for Leqembi (lecanemab) solution for the treatment of Alzheimer's disease. Leqembi was approved under the accelerated approval pathway for the treatment of Alzheimer's disease in January, 2023. Confirmatory studies are studies to verify and describe the clinical benefit of a product after it receives accelerated approval. The committee will discuss the confirmatory study conducted to fulfill the post-marketing requirement detailed in the January 6, 2023 approval letter.

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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, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration