The FDA posted to its set a warning letter previously sent to Owens & Minor, Inc. dba American Contract Systems, following an inspection ...
However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation ...
There are several forms of communications FDA may send to signify an issue. FDA may send a company a notice of a violation in ...
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 ...
In its letter to Intercept, the FDA also said it was continuing to consider data from a post-marketing study called 747-302 ...
Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...
An ad-hoc analysis found a higher rate of severe and life-threatening infections in patients with RET-mutant lung cancer ...
The e-cigarettes include functions meant to appeal to youth, such as receiving text or call notifications, according to ...
The U.S. Food and Drug Administration has lifted a clinical hold on three cell therapies being developed by CARsgen ...
The "FDA Inspection Preparedness and Compliance" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...
A Prisons and Probation Ombudsman (PPO) report into his death revealed that Cox, a long-time drug-user, had left a letter ...