Rather than pursuing a new regulatory pathway, Q'Apel said it is discontinuing the recalled system “as part of its strategic ...

The Food and Drug Administration laid out these inspection findings in warning letters, accusing the companies of committing “significant violations” of federal laws, according to an FDA staff ...

The FDA sent letters to 3 formula companies with quality control concerns. The FDA has sent warning letters to three formula companies, red-flagging concerns about serious quality control issues ...

U.S. cases of severe side effects from exposure to tianeptine have increased from 11 in total between 2000 and 2013 to 151 in ...

The U.S. Food & Drug Administration has issued a warning concerning tianeptine, also known as "gas station heroin," due to ...

Sprout Pharmaceuticals failed to include drug risk information in a promotional social media post, the FDA said in a warning ...

The U.S. FDA has taken off the gloves when it comes to device warning letters. One recent example is the April 3 warning letter to Bioptimal International Ltd., of Shenzen, China, which did not score ...