The FDA classified a nationwide recall of chocolate products from Weaver Nut Company as class I -- the highest risk level -- ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided a rare glimpse in | ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The FDA has called a plan to publish certain complete response letters (CRLs) for medicines it has rejected after an initial ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

Enhance FDA compliance with our expanded training on inspection processes, common issues, and strategies for prevention. Gain insights into Form 483 and warning letter prevention, root cause analysis, ...

The FDA has approved a long-acting drug to protect dogs against fleas and ticks. The drug, Bravecto Quantum, is given by injection and must be prescribed by a licensed veterinarian.

An AI healthcare platform analyzed 13 years of FDA data to identify companies with highest recall rates and most dangerous ...

A young Pittsburgh-area police officer died by suicide and pointed to Lasik eye surgery complications as the reason.

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and ...

The contents of the message accused the recipient of being involved in drug crimes and demanding $2,000 to avoid jail time.