Search results for "FDA update"
Automated reprocessors validated for use in specific duodenoscopes
The FDA had requested validation testing data from all companies that have automated endoscope reprocessors labeled to reprocess endoscopes because of the potential association with patient infection.
https://gastroenterology.acponline.org/archives/2018/04/27/8.htm
27 Apr 2018
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
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
Updated design, labeling cleared for duodenoscope
The changes aim to reduce the potential for patient fluids to leak into the closed elevator channel and underneath the distal cap.
https://gastroenterology.acponline.org/archives/2018/02/23/8.htm
23 Feb 2018
Boxed warning added to liver disease drug
The drug has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis, which increases the risk of serious liver injury, the FDA said.
https://gastroenterology.acponline.org/archives/2018/02/23/7.htm
23 Feb 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
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
Batch of senna laxatives recalled
The recall follows a customer report that a bottle labeled as senna laxative actually contained naproxen sodium.
https://gastroenterology.acponline.org/archives/2018/02/23/11.htm
23 Feb 2018
Proton-pump inhibitor recalled
One lot of pantoprazole sodium for injection (40 mg per vial) was recalled in December.
https://gastroenterology.acponline.org/archives/2018/01/26/6.htm
26 Jan 2018
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