The FDA on June 25 announced a class I recall of nearly 1.5 million insulin syringes.
Insulin and certain other biologic drugs have a new pathway for biosimilar or interchangeable products, the FDA announced on March 23. ... said. Historically, it was more difficult to develop generic versions of these biologic drugs under the Federal Food
https://diabetes.acponline.org/archives/2018/12/14/6.htm. The updated recommendations apply to industry and, when finalized, will update previous guidance issued in 2016. ... The FDA has issued draft guidance to help ensure the accuracy, reliability, and
The FDA on Dec. 13, 2019, authorized marketing of the Tandem Diabetes Care Control-IQ Technology, the first interoperable, automated glycemic controller.
The FDA has approved ertugliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, as an adjunct to diet and exercise for adult patients with type 2 diabetes, as of Dec. ... The most common adverse reaction is female genital mycotic infections. The
The FDA in January approved an expanded indication for the Integra Omnigraft Dermal Regeneration Matrix to treat certain diabetic foot ulcers that last longer than 6 weeks.
The FDA has requested clinical trial data on saxagliptin (Onglyza and Kombiglyze XR) to investigate a possible increase in heart failure in patients taking the drug. ... The manufacturer is expected to submit the data to the FDA by early March 2014,
https://diabetes.acponline.org/archives/2013/05/10/13.htm. The FDA is investigating reports of possible increased risk of pancreatitis and precancerous findings of the pancreas from incretin mimetic drugs ... The FDA is investigating reports of possible
The SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled because they may report falsely low blood glucose levels, the FDA announced
The FDA announced on Jan. 4 that Nostrum Laboratories Inc. is recalling an additional lot of metformin hydrochloride extended-release tablets USP (750 mg) because the tablets have been found to