Bringing a new drug to market in the United States is one of the toughest regulatory journeys in the world. The U.S. Food and Drug Administration (FDA) closely examines every submission, and many applications face rejection, delay, or multiple rounds
The U.S. Food and Drug Administration (FDA) closely monitors dietary supplement manufacturing through inspections. When problems are found, the agency issues Form 483 observations, which list the ways a company has failed to meet current Good Manufac
