Editorials - (2025) Volume 11, Issue 3
Bringing a new drug to market in the United States is a rigorous, multiphase journey governed by the U.S. Food and Drug Administration (FDA). For pharmaceutical innovators, understanding this process is not just a regulatory necessity—it’s a strategic imperative. From discovery to post-marketing surveillance, each stage of FDA approval is designed to ensure that new therapies are safe, effective, and beneficial to public health. This article breaks down the FDA approval process and high1lights key insights for innovators navigating this complex landscape.
Abstract
Bringing a new drug to market in the United States is a rigorous, multiphase journey governed by the U.S. Food and Drug Administration (FDA). For pharmaceutical innovators, understanding this process is not just a regulatory necessity—it’s a strategic imperative. From discovery to post-marketing surveillance, each stage of FDA approval is designed to ensure that new therapies are safe, effective, and beneficial to public health. This article breaks down the FDA approval process and highlights key insights for innovators navigating this complex landscape.
Published: 26-Sep-2025, DOI: 10.35248/2471-268X.24.11(3).002
Copyright:This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
