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

The US Food and Drug Administration has issued a warning letter to Cipla after receiving thousands of complaints of defective products in the last couple of years. In the warning letter issued on ...

The U.S. Food and Drug Administration has issued a warning letter to the web-based business Toltrazuril Shop, informing the ...

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

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 ...

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

The Food and Drug Administration on Wednesday warned nine online retailers and one manufacturer for selling or distributing ...

The U.S. Food and Drug Administration has lifted a clinical hold on three cell therapies being developed by CARsgen ...

Intercept’s US president Vivek Devaraj said the pharma company still believes in the evidence supporting the liver disease ...

Robert F. Kennedy Jr., one of President-elect Donald J. Trump’s advisers on health, is taking aim at the agency’s oversight ...

An ad-hoc analysis found a higher rate of severe and life-threatening infections in patients with RET-mutant lung cancer ...