FDA Roundup: May 24, 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 announced that Medline Industries, LP, a firm marketing and distributing plastic syringes made in China within the U.S., initiated a recall to stop using affected products which includes unauthorized plastic syringes made in China. Additionally, on Tuesday, the FDA announced that Jiangsu Shenli Medical Production Co. Ltd, a China-based manufacturer of plastic syringes, initiated a recall to stop using its unauthorized plastic syringes. The FDA recommendations have not changed. The FDA will continue efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available. 
• On Thursday, the FDA published the “Catching Up with Califf:” “Treatment Using Medication for Opioid Use Disorder Can Save Lives,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. In this "Catching Up with Califf,” Dr. Califf discusses the new campaign the agency has launched called “Prescribe with Confidence” to help raise awareness about OUD and to provide resources for clinicians. There are many people who could benefit from treatment but who have not received any medications for OUD.
• On Thursday, the FDA cleared for marketing CamAPS FX by CamDiab Ltd, a mobile app (prescription-only device) intended for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in people two years of age or older. This is the first of its kind for use in pregnant patients who may have complications from type 1 diabetes. The device works with an integrated continuous glucose monitor to control a compatible insulin pump. The app is designed to be compatible with other interoperable devices that meet pre-specified acceptance criteria in a predetermined change control plan provided by the sponsor and cleared by the FDA as part of the premarket submission. This is the latest example of the FDA’s ongoing commitment to help advance the development and expansion of products that can improve the management of type 1 diabetes.
• On Thursday, the FDA issued a supplemental approval for Safe-Guard (fenbendazole) for the treatment and control of gastrointestinal worms (Aulonocephalus spp.) in wild quail. This approval provides a tool for wildlife managers to treat and control these parasites in wild quail populations. While there are currently FDA-approved drugs for use in farmed quail, this is the first animal drug approval for use in wild quail and for this indication. 
• On Wednesday, the FDA made new user-friendly updates to the Searchable Tobacco Products Database including improved search capabilities and more accommodations for accessing the database on mobile devices.   In March, FDA launched the database, that contains a list of tobacco products—including e-cigarettes—that may be legally marketed in the United States.  

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