The FDA posted to its set a warning letter previously sent to Owens & Minor, Inc. dba American Contract Systems, following an inspection ...

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after ...

However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation ...

The U.S. Food and Drug Administration has added a new warning to drugs including Ozempic and Wegovy, cautioning that patients taking the drugs may be at a higher risk of inhaling gastric contents ...

Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...

Those ever-present TV drug ads showing patients hiking, biking or enjoying a day at the beach could soon have a different ...

In a recent move, the FDA has added a warning to the labels of all GLP-1 receptor agonist drugs, commonly prescribed for weight loss and blood sugar control in diabetes. This new label states that ...

iRhythm Technologies has announced that the US Food and Drug Administration (FDA) has cleared design updates made to its Zio AT device. The Zio AI continuous monitoring system combines a wearable ...

Hong Kong’s biggest lawyer group has sent warning letters to some of its members for accepting fees from a now-defunct defence fund for protesters involved in the 2019 social unrest, after the ...

the US Food and Drug Administration (FDA) updated the labels for all glucagon-like peptide 1 receptor agonists (GLP-1 RA) with a warning about pulmonary aspiration during general anesthesia or ...