Search results for "FDA Update"
FDA places limits on OTC loperamide
The agency is working with manufacturers to use blister packs or other single-dose packaging and curb the number of doses contained in each package.
https://gastroenterology.acponline.org/archives/2018/02/23/9.htm
23 Feb 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
New drug approved to treat digestive tract cancers
The orphan drug is indicated to treat adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
https://gastroenterology.acponline.org/archives/2018/02/23/10.htm
23 Feb 2018
Sodium polystyrene sulfonate should be taken separately from other oral meds, FDA advises
The FDA's recommendation follows a study finding that sodium polystyrene sulfonate also binds to many common oral medications, which decreases their absorption and effectiveness.
https://gastroenterology.acponline.org/archives/2017/09/22/6.htm
22 Sep 2017
Duodenoscopes recalled
The recall of ED-530XT duodenoscopes by Fujifilm includes replacement of the ED-530XT forceps elevator mechanism (including the O-ring seal), replacement of the distal end cap, and new operation manuals.
https://gastroenterology.acponline.org/archives/2017/07/28/9.htm
28 Jul 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
FDA alerts clinicians about cross-contamination risk with certain endoscope connectors
Endoscope connectors labeled for use in multiple patients within a 24-hour period without reprocessing are not recommended for use because the FDA has not received acceptable testing data demonstrating their safety.
https://gastroenterology.acponline.org/archives/2018/04/27/9.htm
27 Apr 2018
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
Biosimilar approved for certain cases of breast, metastatic stomach cancer
The drug is the first FDA-approved biosimilar to treat breast or stomach cancer and the second FDA-approved biosimilar to treat cancer.
https://gastroenterology.acponline.org/archives/2017/12/22/6.htm
22 Dec 2017