The Food and Drug Administration (FDA) approve drugs for certain health conditions. When a doctor prescribes a drug off-label, they are prescribing it for a different condition or at a different ...

Certificate of Label Approval (or COLA) can be one of the more frustrating processes for brewers. Each label must be approved by the Alcohol and Tobacco Tax and Trade Bureau (TTB). Once the COLA is ...

The U.S. Food Safety and Inspection Service (FSIS) recently issued a final rule expanding the circumstances under which it will generically approve the labels of meat, poultry, and egg products. As a ...

Both the U.S. Court of Appeals for the Second Circuit and district courts have ruled against the Food and Drug Administration (FDA) in two widely publicized cases involving the agency’s enforcement of ...