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The FDA also encourages users to carry backup supplies for insulin delivery should pump failure persist. Customers with any questions or concerns regarding the recall can reach Tandem Diabetes ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
In November 2011, the company received FDA clearance to market the t:slim Insulin Pump, the first ever touch-screen insulin pump. [10] In February 2013, the company received FDA clearance to market the t:connect Diabetes Management Application, a Mac and PC-compatible data management application that provides t:slim Pump users and their healthcare providers a way to display data from the pump ...
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Mylan’s second recall of Insulin Glargine this year. For premium support please call: 800-290-4726 more ways to reach us
Pump and infusion set (catheter) placement Insulin basal bolus profile. Insulin pumps are drug delivery devices used to treat patients with type 1 and type 2 diabetes. The Minimed Paradigm REAL-Time and Continuous Glucose Monitoring (CGM) system, which received FDA clearance in 2006, uses tubing and a reservoir with rapid-acting insulin.
Now, the maker of a once-weekly insulin injection is seeking approval from the US Food and Drug Administration, but a committee of agency advisers is divided on whether the benefits of the product ...