Drug safety has always been at the heart of healthcare. Every treatment, no matter how promising, carries some level of risk. This is why the science and practice of pharmacovigilance (PV) exist. PV is more than a regulatory requirement, it is the on
Top Reasons FDA Rejects Drug Applications: Lessons from Safety and Adverse Event Data
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