Search results for "FDA update"
FDA issues statements on counterfeit, compounded semaglutide
The agency warned about a single lot of counterfeit semaglutide and announced that it would begin enforcing regulations against pharmacies and physicians compounding the drug now that the shortage is over.
https://diabetes.acponline.org/archives/2025/05/09/8.htm
9 May 2025
Warning on Dexcom CGM manufacturing
The FDA sent a warning letter about methods used in the manufacture, packing, storage, or installation of the G6 and G7 continuous glucose monitors (CGMs).
https://diabetes.acponline.org/archives/2025/04/11/8.htm
11 Apr 2025
Approvals for biosimilar, CGM software
The FDA approved a biosimilar insulin and expanded its approval of an interoperable automated glycemic controller for use with continuous glucose monitors (CGMs) in recent weeks.
https://diabetes.acponline.org/archives/2025/03/14/8.htm
14 Mar 2025
FDA warns about smartphone systems, glucose tests
Smartphone settings may cause notifications from diabetes devices to be missed, and some glucose and ketone meters were recalled.
https://diabetes.acponline.org/archives/2025/02/14/8.htm
14 Feb 2025
Recent FDA announcements affect diabetes care
Tirzepatide received a new indication, liraglutide got a generic version, and insulin syringes were recalled, in FDA news.
https://diabetes.acponline.org/archives/2025/01/10/7.htm
10 Jan 2025
Recent FDA announcements deal with insulin pumps
The agency announced a recall of a series of Medtronic insulin pumps and offered information about preventing damage to pumps and monitors during CT scans and X-rays.
https://diabetes.acponline.org/archives/2024/11/08/9.htm
8 Nov 2024
Recall, expanded indication for different CGMs
Some sensors for the Freestyle Libre 3 continuous glucose monitor (CGM) were recalled, and an interoperable automated glycemic controller was approved for insulin-dependent type 2 diabetes.
https://diabetes.acponline.org/archives/2024/10/11/8.htm
11 Oct 2024
Warnings about compounded semaglutide, glucose sensors
Compounded semaglutide may lead to dosing errors and some FreeStyle Libre 3 sensors may be inaccurate, the FDA said.
https://diabetes.acponline.org/archives/2024/08/09/10.htm
9 Aug 2024
FDA advisors vote against weekly insulin for type 1 diabetes
In other diabetes-related actions, the FDA recently authorized marketing of an app for automated insulin delivery and warned about software issues with an existing app and insulin pump.
https://diabetes.acponline.org/archives/2024/06/14/11.htm
14 Jun 2024
FDA warns about smartwatches, rings to measure glucose
Smartwatches and smart rings that claim to measure blood glucose levels without piercing the skin are being sold commercially, but none have been approved by the FDA, the agency warned.
https://diabetes.acponline.org/archives/2024/03/08/8.htm
8 Mar 2024
First over-the-counter CGM cleared for marketing
The integrated continuous glucose monitor (CGM) is intended for anyone ages 18 years and older who does not use insulin.
https://diabetes.acponline.org/archives/2024/03/08/7.htm
8 Mar 2024
CGM software authorized, infusion sets recalled, tirzepatide approved for obesity
The FDA cleared a software system that works with continuous glucose monitors (CGMs) and insulin pumps for marketing and announced the recall of some lots of insulin infusion sets.
https://diabetes.acponline.org/archives/2023/12/08/9.htm
8 Dec 2023
Two diabetes drugs go generic
A dipeptidyl peptidase-4 inhibitor and sodium-glucose cotransporter-2 inhibitor recently had first-time generic versions approved.
https://diabetes.acponline.org/archives/2023/11/10/9.htm
10 Nov 2023
CBT device for type 2 diabetes receives OK to market
The FDA recently authorized marketing of a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy (CBT) to adult patients with type 2 diabetes.
https://diabetes.acponline.org/archives/2023/08/11/8.htm
11 Aug 2023
Bionic pancreas cleared for patients with type 1 diabetes
The new automated insulin dosing system, called the iLet Bionic Pancreas, is intended for use in patients ages 6 years and older with type 1 diabetes.
https://diabetes.acponline.org/archives/2023/06/09/8.htm
9 Jun 2023
Insulin pump approved for type 1 diabetes
The FDA recently approved the MiniMed 780G System for continuous delivery of basal insulin at selectable rates and the administration of insulin boluses at a selectable amount for the management of type 1 diabetes in patients ages 7 years and older requiring insulin.
https://diabetes.acponline.org/archives/2023/05/12/9.htm
12 May 2023
New safety alert for certain continuous glucose monitoring systems
Glucose readers in the FreeStyle Libre product family have the potential for battery swelling and overheating if not properly stored, charged, or used.
https://diabetes.acponline.org/archives/2023/04/14/7.htm
14 Apr 2023
FDA clears marketing of mobile app for automated insulin dosing in type 1 diabetes
The prescription-only mobile application is intended for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in persons ages 6 years and older.
https://diabetes.acponline.org/archives/2023/02/10/6.htm
10 Feb 2023
Drug approved to delay onset of stage 3 type 1 diabetes
The first-in-class therapy, indicated in adults and pediatric patients ages 8 years and older who currently have stage 2 type 1 diabetes, is administered by IV infusion once daily for 14 consecutive days.
https://diabetes.acponline.org/archives/2022/12/09/11.htm
9 Dec 2022
Diabetes device recalled due to risk of fire
The FDA recently announced a class I recall of the Omnipod DASH Insulin Management System Personal Diabetes Manager due to reports of battery issues, including battery swelling, fluid leakage, and extreme overheating that may pose a fire hazard.
https://diabetes.acponline.org/archives/2022/12/09/10.htm
9 Dec 2022