Open Access. Powered by Scholars. Published by Universities.®

Law Commons

Open Access. Powered by Scholars. Published by Universities.®

Journal Articles

Food and Drug Law

Device

Articles 1 - 1 of 1

Full-Text Articles in Law

Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore Jan 2022

Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore

Journal Articles

In many critical industries, the Food and Drug Administration’s (FDA’s) marketing authorization decisions determine the range of products available in the United States. Because of the broad scope of the FDA’s marketing authorization responsibilities, the existing scholarship focuses on individual product categories, or small groups of product categories, regulated by the agency. This Article identifies how the existing literature has overlooked important connections between the FDA’s different marketing authorization programs. These connections suggest both explanations for existing programs and strategies for potential reforms.

The Article sets forth a two-level framework for analyzing the FDA’s marketing authorization role. At the first …