Search results for "FDA update"
FDA recommends transition to duodenoscopes with disposable endcaps
While a full transition away from conventional duodenoscopes to innovative models will take time, health care facilities should develop plans to transition away from older models that have fixed endcaps, the FDA said.
https://gastroenterology.acponline.org/archives/2019/09/27/7.htm
27 Sep 2019
Ranitidine recalled due to detection of impurity
In response to the detection of N-nitrosodimethylamine, a probable carcinogen, several companies have recalled the histamine H2 receptor antagonist, although FDA testing has found that levels detected are low.
https://gastroenterology.acponline.org/archives/2019/11/22/6.htm
22 Nov 2019
Incontinence management system recalled due to potential interference with other devices
About a month after issuing an urgent medical device correction, the manufacturer announced a class I recall of the WatchCare Incontinence Management System due to potential radio frequency interference with other medical devices.
https://gastroenterology.acponline.org/archives/2022/12/23/8.htm
23 Dec 2022
Drug cleared to treat moderately to severely active ulcerative colitis
It is the first oral medication to be approved for chronic use in this population.
https://gastroenterology.acponline.org/archives/2018/06/22/6.htm
22 Jun 2018
FDA sends warning to duodenoscope manufacturers
The manufacturers have not fulfilled requirements to conduct studies assessing the real-world effectiveness of device reprocessing, the FDA said.
https://gastroenterology.acponline.org/archives/2018/03/23/6.htm
23 Mar 2018
IBS-D drug should not be prescribed to patients without gallbladders
The FDA suggests that clinicians should consider alternatives to eluxadoline in this population.
https://gastroenterology.acponline.org/archives/2017/03/24/8.htm
24 Mar 2017
New HCV drug combo approved
The fixed-dose tablet combines the previously approved drugs sofosbuvir and velpatasvir with a new drug, voxilaprevir.
https://gastroenterology.acponline.org/archives/2017/07/28/10.htm
28 Jul 2017
Regorafenib now FDA-approved to treat hepatocellular carcinoma
Approved use of the drug has been expanded to include treatment of patients with hepatocellular carcinoma who have been treated with sorafenib.
https://gastroenterology.acponline.org/archives/2017/05/26/7.htm
26 May 2017
Drug for chronic idiopathic constipation approved
The oral medication is taken once per day and works in the upper GI tract to stimulate secretion of intestinal fluid, supporting regular bowel function.
https://gastroenterology.acponline.org/archives/2017/01/27/7.htm
27 Jan 2017
Marketing authorized for endoscopic sleeve gastroplasty systems
The systems are the first to be authorized by the FDA for the minimally invasive weight-loss procedure, which is intended for adults with obesity who have not been able to lose weight or maintain weight loss through measures such as diet and exercise.
https://gastroenterology.acponline.org/archives/2022/08/26/12.htm
26 Aug 2022