The FDA's Pivotal Role in Global Therapeutic Product Availability.

Abstract

Since its inception over a century ago, the U.S. Food and Drug Administration (FDA) has been recognized as the gold standard for assessing the quality, safety, and efficacy of therapeutics. Its scientific expertise and regulatory agility have been applied to a wide range of products, including small molecules, biologics, vaccines, and medical devices. The FDA's global leadership was evident during the COVID-19 pandemic, as it expedited the development and approval of vaccines while maintaining s