Step-by-Step Guide to FDA Regulatory Affairs and Drug Approval Process Comprehensive FDA Regulatory Affairs Guide for Pharma Success Introduction to FDA Regulatory Affairs and Its Importance The United States Food and Drug Administration (FDA) is the primary regulatory body governing pharmaceuticals, biologics, and medical devices in the U.S. Its mandate is to ensure the safety, efficacy, and quality of products that reach patients. For pharmaceutical companies, navigating FDA regulatory affairs is not merely a compliance requirement but a core strategy that defines success in one of the world’s largest healthcare markets. The FDA’s influence extends globally, with approval in the…