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 standards for quality, safety, and effectiveness. The FDA serves both domestic and international missions. As the primary approver of most new medicines, it ensures the timely availability of innovative therapeutics for the American public. Moreover, its longstanding leadership in regulatory activities has established it as an international paragon upon which regulatory authorities serving hundreds of millions of people rely. The FDA must maintain its position as the global leader in biopharmaceutical and medical device assessments. This is essential for preserving public health in the U.S., playing a crucial role in fostering bio-innovation and the economic viability of the pharmaceutical sector, and facilitating the global availability of innovative products to benefit worldwide public health.