Food and Drug Law Journal

Published for more than 70 years, the Food and Drug Law Journal is a peer-reviewed quarterly devoted to the scholarly analysis of legislation, regulations, court decisions, and public policies affecting the development, manufacture, marketing, and use of foods, drugs, biologics, cosmetics, medical devices, and tobacco.

Since 2015 the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law.

The latest issue of the Food and Drug Law Journal has just been released.  

You can review the highlighted article, "FDA's Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence" by Frank J. Sasinowski and Alexander J. Varond. The authors researched the nineteen non-AIDS, non-cancer Subpart H approval determinations over the Accelerated Approval program's 24-year existence. Based on a detailed analysis, they found that FDA exercises considerable regulatory flexibility in these expedited reviews. 

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Volume 71, Number 1 Table of Contents

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The Food and Drug Law Journal

  • Clarifies the complex regulation and legislation affecting the food, drug, cosmetic, medical device, and healthcare technology industries.
  • Explores the possible future implications of proposed regulations and policy trends.
  • Analyzes critical court decisions in food and drug law, including intellectual property, antitrust, constitutional and criminal law issues related to the health law field.
  • Looks beyond our borders to assess how food- and drug-related issues are regulated in other countries.
  • Provides a neutral forum for intelligent discussion and debate among authors from private industry, government agencies, and academic institutions.