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The International Regulation of Genetically Modified Organisms: Importing Caution Into the U.S. Food Supply

Posted on May 2006 by Debra M. Strauss

61 FOOD AND DRUG LAW JOURNAL 167-196 (2006). Biotechnology in the food industry has developed rapidly in recent years. In the United States, genetically modified organisms in food have increased e...read more

Amicus Curiae Efforts to Reform Product Liability at the Food and Drug Administration: FDA's Influence on Federal Preemption of Class III Medical Devices and Pharmaceuticals

Posted on November 2005 by Mark C. Levy & Gregory J. Wartman

60 Food and Drug Law Journal 495-510 (2005). Since President George W. Bush took office in 2000, the Food and Drug Administration (FDA) has used amicus curiae briefs in medical device and pharma...read more

Reflections on Historical, Scientific, and Legal Issues Relevant to Designing Approval Pathways for Generic Versions of Recombinant Protein-Based Therapeutics and Monoclonal Antibodies

Posted on May 2005 by David M. Dudzinski

60 Food and Drug Law Journal 143-260 (2005). The Food and Drug Administration (FDA) approves generic drugs for marketing in the United States. Thus, FDA also necessarily bears the final responsib...read more

Takings Issues in the Approval of Generic Biologics

Posted on March 2005 by John C. Yoo

60 Food and Drug Law Journal 33-44 (2005). Recent efforts to streamline the Food and Drug Administration's (FDA's) drug approval processes include a proposal to rely on proprietary data supplied ...read more

Legal Implications of Pharmacogenomics Regarding Drug Trials, Drug Labeling, and Genetic Testing for Drug Prescription: An International Approach

Posted on November 2004 by Tilo Mandry

59 Food and Drug Law Journal 519-536 (2004). Pharmacogenomics applies genomic technology to discover and develop drugs, as well as to treat patients with drugs more effectively. This article iden...read more

European Opposition to Exclusive Control Over Predictive Breast Cancer Testing and the Inherent Implications for U.S. Patent Law and Public Policy: A Case Study of the Myriad Genetics’ BRCA Patent Controversy

Posted on March 2004 by Jordan Paradise

Issue: 59 Food and Drug Law Journal 133-154 (2004). Controversy over gene patents has arisen due to a variety of issues, including their relatively recent arrival into the patent realm, their gra...read more

The National Childhood Vaccine Injury Act Turns Fifteen

Posted on August 2001 by Elizabeth C. Scott

Issue: 56 Food and Drug Law Journal 351-366 (2001). The discovery and widespread use of vaccines against many infectious diseases represents one of the greatest public health developments of the ...read more

Biotechnology on the RAC—FDA/NIH Regulation of Human Gene Therapy

Posted on November 2000 by Joseph M. Rainsbury

Issue: 55 Food and Drug Law Journal 575-600 (2000) Gene therapy, a procedure in which healthy genes are spliced into the cells of sick patients, constitutes the cutting edge of medical research. I...read more

The International Harmonization of Human Tissue Regulation: Regulatory Control Over Human Tissue Use and Tissue Banking in Select Countries and the Current State of International Harmonization Efforts

Posted on August 2000 by Barbara Indech

Issue: 55 Food and Drug Law Journal 343-372 (2000) Human tissues play a critical role in modern medicine. Beyond immediate therapeutic uses, tissues (unlike organs) may be stored indefinitely in t...read more

The Safety of Genetically Modified Soybeans: Evidence and Regulation

Posted on May 2000 by Steven H. Yoshida

Issue: 55 Food and Drug Law Journal 193-208 (2000). Genetically modified foods (GMFs) have generated a great deal of controversy. Among other criticisms, GMFs are considered potentially unsafe to ...read more

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