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 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 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 ...

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 ...

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

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 ...

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

Drug dealers are advertising where to buy drugs on government, school and research journal websites, and it’s been an issue for over a year now.

The FDA became aware of the problem after a patient submitted a complaint to the regulator that a vial of semaglutide from ...

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

South offers this regular column as a public service to help consumers make informed decisions and avoid scams.