The FDA has issued warning letters to United King Foods Private Limited in Pakistan and Mother Earth Minerals, Inc. in Ogden, UT, for significant violations of federal food safety regulations.

The FDA, under Health Secretary Robert F. Kennedy Jr., has taken another step to question the safety of Covid-19 vaccines.

The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men.

The U.S. Food & Drug Administration has issued a warning concerning tianeptine, also known as "gas station heroin," due to its easy access and potential for harm or death.

The OPDP issued a warning letter to the drugmaker—dated May 29 and publicly released this week—to express concerns over an Instagram post from Sprout’s CEO about Addyi, the company’s ...

Rutgers Health researchers found that lamotrigine, a widely prescribed antiseizure medication, to be safe in older adults with epilepsy, contrary to a safety warning by the Food and Drug ...

Rutgers Health researchers found that lamotrigine, a widely prescribed antiseizure medication, to be safe in older adults with epilepsy, contrary to a safety warning by the Food and Drug ...

Layoffs at the FDA, USDA and CDC could erode the U.S. food safety system. Experts aren’t so worried about milk or chicken today; they’re concerned about the future.

Rechon Life Sciences, a Sweden-based CDMO, was hit with a warning letter from the FDA following an inspection that uncovered unsanitary conditions at its aseptic production plant.

As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are ...