For more than 60 years, this award-winning journal has offered readers scholarly, in-depth, analytical articles, providing insight into the actions of FDA, FTC, and USDA, how the courts interpret these actions, and the reaction of industry. Articles published in the Food and Drug Law Journal are heavily cited and reviewed by your peers. The Food and Drug Law Journal is published four times per year. Articles and Abstracts
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The Constitutional Protection of Trade Secrets and Patents under the Biologics Price Competition and Innovation Act of 2009
Your Business in Court: 2009-2010 66:2
Global Regulatory Standards for the Approval of Biosimilars
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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.
"FDLI's Food and Drug Law Journal is far and away the best publication of its type that I have read. It balances serious and scholarly work with a practical treatment of current issues. It's the only 'law review like' publication that I spend any time with." — Joseph W. Metro, Partner, Reed Smith LLP
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Three Journal Articles Cited in Court Case
Three articles from the Food & Drug Law Journal were cited in the court case of U.S. v. Lane Labs-USA, Inc. The U.S. Court of Appeals for the Third Circuit in Philadelphia ruled that FDA can exercise its enforcement powers by seeking and obtaining a restitution award against a dietary supplement manufacturer.
The first article, entitled "Can FDA Seek Restitution or Disgorgement?" (Volume 58, Issue 2, Food and Drug Law Journal, 2003), examines the asserted legal underpinnings for FDA's invocation of this powerful enforcement tool, as well as the arguments against the use of restitution and disgorgement. Co-authors Jeffrey N. Gibbs and John R. Fleder explain how FDA's use of restitution and disgorgement is unsupported by statutory authority, case law, and fundamental canons of statutory construction.
The second article, entitled "The Authority of a Court to Order Disgorgement for Violations of the Current Good Manufacturing Practices Requirement of the Federal Food, Drug, and Cosmetic Act" (Volume 58, Issue 2, Food and Drug Law Journal, 2003), is co-authored by Erika King and Elizabeth M. Walsh. It responds to an article, published in the Food and Drug Law Journal in 2000, in which the FDA's Deputy Chief Counsel for Litigation presented a legal justification for the disgorgement award included in the agency's 1999 consent decree with Abbott Laboratories.
The third article, entitled "Anchors Away: The Food and Drug Administration's Use of Disgorgement Abandons Legal Moorings" (Volume 59, Issue 1, Food and Drug Law Journal, 2004), addresses the fundamental elements of the equitable remedy of disgorgement and demonstrates that FDA's recent actions depart significantly from the historic precedents. Co-authored by William W. Vodra and Arthur N. Levine, this article recommends that FDA take affirmative actions to ensure that this enforcement tool is not improperly used in the future.
FDLI is honored to have the articles cited in such an important case and congratulates these
co-authors for their achievements.
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Vodra/Levine Food and Drug Law Journal Article Wins 2005 Burton Award for Legal Achievement
William W. Vodra and Arthur N. Levine, partners in the Washington, DC office of Arnold & Porter LLP, received a 2005 Burton Award for Legal Achievement for their article entitled "Anchors Away: The Food and Drug Administration's Use of Disgorgement Abandons Legal Moorings," 59 Food and Drug Law Journal 1-30 (2004).
The article addresses the fundamental elements of the equitable remedy of disgorgement and discusses the Food and Drug Administration's (FDA's) pursuit of such to enforce alleged violations of the Federal Food, Drug, and Cosmetic Act. The authors demonstrate that FDA's recent actions depart significantly from historic precedents. Because profound issues are presented for the agency, courts, and regulated companies, the authors recommend that FDA take affirmative actions to ensure that this enforcement tool is not improperly used in the future. Further, they argue for the agency to seek independent case-by-case judicial evaluation of the remedy.
The Burton Foundation presented the 2005 Burton Awards for Legal Achievement at a June 6th event held in the Great Hall of the Library of Congress, Washington, DC. The awards are given to promote clear, cogent, and effective writing; reward eloquent writing for scholarly works; advance the plain language style of writing for statutory and regulatory drafting; and recognize other contributions and accomplishments in law.
This was the third time in the past six years that Journal articles have won the Burton Award. Sarah E. Taylor and Harold J. Feld received the 2000 Burton Award for their article entitled "Promoting Functional Foods and Nutraceuticals on the Internet," 54 Food and Drug Law Journal 423-452 (1999). Peter J. Goss, Debra L. Worthington, Merrie Jo Stallard, and Joseph M. Price received the 2002 Burton Award for their article entitled "Clearing Away the Junk: Court Appointed Experts, Scientifically Marginal Evidence, and the Silicone Gel Breast Implant Litigation," 56 Food and Drug Law Journal 227-240 (2001).
FDLI extends its thanks and congratulations to these co-authors for their achievement.
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FDLI's Food and Drug Law Journal Receives ASAE's Prestigious Gold Circle Award
The Food and Drug Law Journal was awarded a 2000 Gold Circle Certificate of Achievement in the category of Peer-Reviewed Journals. Each year, the Communication Section of the American Society of Association Executives (ASAE) presents Gold Circle awards to the best in association publishing and public relations. The award has consistently recognized excellence in nonprofit communications for more than 20 years.
For over 50 years, the Food and Drug Law Journal has been devoted to the analysis of legislation, regulation, judicial decisions, and public policies affecting the development, manufacture, marketing, and use of foods, drugs, biologics, cosmetics, and medical devices. In accordance with FDLI's mission to advance the public health by promoting an understanding of this field of law and regulation, the Journal provides a neutral forum for scholarly debate, continuing education, and exchange of views in accordance with the highest professional standards.
In addition to the Certificate of Achievement, FDLI was honored at a breakfast on December 13, 2000 for Gold Circle award winners.
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Taylor/Feld Article Wins 2000 Burton Award for Legal Achievement
Sarah E. Taylor and Harold J. Feld received a 2000 Burton Award for Legal Achievement for their article entitled "Promoting Functional Foods and Nutraceuticals on the Internet," 54 Food and Drug Law Journal 423-452 (1999). The article discusses key legal considerations in developing promotions of functional foods and nutraceuticals on the Internet such as Food and Drug Administration and Federal Trade Commission regulatory requirements, the scope of state law jurisdictions, and laws protecting consumer privacy rights.
The Burton Foundation presented the 2000 Burton Awards for Legal Achievement at a ceremony on July 12, 2000. The awards were given to promote clear, cogent and effective writing; reward eloquent writing for scholarly works; advance the plain language style of writing for statutory and regulatory drafting; and recognize other contributions and accomplishments in law. FDLI extends its thanks and congratulations to Sarah Taylor and Harold Feld for their achievement.
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