JD Supra14d
Responding to Letters from FDA
There are several forms of communications FDA may send to signify an issue. FDA may send a company a notice of a violation in ...
FDA posts warning letter sent to Owens & Minor related to August inspection
The FDA posted to its set a warning letter previously sent to Owens & Minor, Inc. dba American Contract Systems, following an inspection ...
Food Safety News12d
FDA issues warning letters to mushroom and produce importers for critical safety violations
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 ...
medtechdive14d
FDA clears iRhythm’s second 510(k) in response to warning letter
However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation ...
MassDevice15d
FDA clears second set of changes to iRhythm Zio AT to resolve warning letter
Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...
Food Safety News1mon
FDA cracks down on food importers for major safety violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...
Becker's Hospital Review11d
FDA warns against California facility making compounded weight loss drugs
The FDA issued a warning to patients and healthcare professionals to refrain from using compounded drugs distributed by Ontario, Calif.-based Fullerton Wellness, expressing concerns about the ...
Reason2d
FDA Recalls 80,000 Pounds of Costco Butter Over Missing Milk Allergy Warning
Last month, the U.S. Food and Drug Administration (FDA ... the packaging lacked a critical allergen warning alerting consumers that butter contains milk. That's right, Costco had to waste 40 ...
oncnursingnews11d
Letter Warns Clinicians of Severe Infections With Pralsetinib for NSCLC
An ad-hoc analysis found a higher rate of severe and life-threatening infections in patients with RET-mutant lung cancer ...
Dallas Morning News8d
FDA adds new warning to weight loss drugs including Wegovy
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 ...
RFK Jr warns he plans on clearing out entire departments of the FDA
Robert F Kennedy Jr, a likely political appointee in Trump’s new government, has already announced his intentions to clear out departments of the Federal Drug Administration. At such a critical moment ...
Yahoo Finance25d
iRhythm secures 510(k) clearance for Zio device updates after FDA warning
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 ...