Search results for "FDA update"
First oral treatment approved for moderate to severe Crohn's disease
Upadacitinib (Rinvoq) is now approved to treat adult patients with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.
https://gastroenterology.acponline.org/archives/2023/05/26/9.htm
26 May 2023
Another warning for endoscope manufacturer after facility inspection in Japan
The warning letter to Olympus Medical Systems Corporation followed previous warning letters issued to the firm and one of its subsidiaries and described numerous violations, including failure to evaluate and report user reports of adverse events.
https://gastroenterology.acponline.org/archives/2023/04/21/7.htm
21 Apr 2023
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
FDA approves first fecal microbiota product
The product, which is prepared from donated, tested stool and administered rectally as a single dose, is indicated for the prevention of recurrent Clostridioides difficile infection in adults who have already completed antibiotic treatment for a recurrence.
https://gastroenterology.acponline.org/archives/2022/12/23/7.htm
23 Dec 2022
Urgent medical device correction for incontinence management system
There is a potential for radio frequency interference between the WatchCare Incontinence Management System and other medical devices in the vicinity, such as insulin pumps, telemetry devices, and infusion injection pumps.
https://gastroenterology.acponline.org/archives/2022/11/18/10.htm
18 Nov 2022
Hepatic artery infusion pumps recalled
The recall was initiated after reports from clinicians that the pumps were delivering medications faster than expected.
https://gastroenterology.acponline.org/archives/2022/09/23/12.htm
23 Sep 2022
Monkeypox may be transmitted through fecal microbiota transplantation
Because of this risk, the FDA determined that additional protections are required for any investigational use of fecal microbiota transplantation if it involves stool donated on or after March 15, 2022.
https://gastroenterology.acponline.org/archives/2022/09/23/10.htm
23 Sep 2022
FDA approves first medication for adults with hepatorenal syndrome
The treatment is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
https://gastroenterology.acponline.org/archives/2022/09/23/11.htm
23 Sep 2022
More laxatives recalled due to microbial contamination
Recalled products were distributed nationwide at CVS drugstore locations.
https://gastroenterology.acponline.org/archives/2022/07/22/10.htm
22 Jul 2022
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