Search results for "FDA update"
Extended-release metformin recalled due to nitrosamine impurities
A company recently expanded a recall of metformin hydrochloride extended-release tablets USP due to excess amounts of N-nitrosodimethylamine.
https://diabetes.acponline.org/archives/2021/01/08/7.htm
8 Jan 2021
FDA clears marketing of first interoperable insulin pump
The pump can be used with various components of diabetes therapy systems, including automated insulin dosing systems, continuous glucose monitors, and blood glucose meters.
https://diabetes.acponline.org/archives/2019/03/08/7.htm
8 Mar 2019
Glucose meter recalled due to incorrect unit of measure
The TRUE METRIX AIR Blood Glucose Meter displayed glucose results in mmol/L rather than mg/dL.
https://diabetes.acponline.org/archives/2020/05/08/7.htm
8 May 2020
FDA urges patients to use caution when injecting insulin with pen needles
The agency offered new recommendations after receiving reports of patients using standard pen needles to inject insulin without removing the inner needle cover.
https://diabetes.acponline.org/archives/2018/10/12/7.htm
12 Oct 2018
Cybersecurity warning issued for certain insulin pumps
The risks are related to the pumps' wireless communication with other devices, such as blood glucose meters and continuous glucose monitoring systems.
https://diabetes.acponline.org/archives/2019/07/12/6.htm
12 Jul 2019
First continuous glucose monitoring system approved to be used with other devices
The system is the first approved to be used with other diabetes devices, such as automated insulin-dosing systems, insulin pumps, or blood glucose meters, according to the FDA.
https://diabetes.acponline.org/archives/2018/04/13/6.htm
13 Apr 2018
CGM system approved for use without finger sticks
A continuous glucose monitoring (CGM) system was approved and some infusion sets were recalled, the FDA recently announced.
https://diabetes.acponline.org/archives/2017/10/13/6.htm
13 Oct 2017
Metformin solution recalled due to contamination
Two lots of metformin hydrochloride oral solution (Riomet), 500 mg/5 mL, were recalled due to fungal contamination, the FDA said.
https://diabetes.acponline.org/archives/2017/12/08/7.htm
8 Dec 2017
Semaglutide injection approved for chronic weight management
First approved to treat type 2 diabetes in 2017, the drug has a new indication for chronic weight management in adults with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related condition, such as type 2 diabetes, and those with a BMI of 30 kg/m2 or greater.
https://diabetes.acponline.org/archives/2021/06/11/11.htm
11 Jun 2021
Insulin, other biologics gain new pathway for biosimilars
The FDA expects that the regulatory transition, mandated by Congress, will support market competition and increase patient access to these drugs.
https://diabetes.acponline.org/archives/2020/04/10/9.htm
10 Apr 2020