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Seton Hall Law

Biotechnology: Books & Treatises



The Rodino Law Library has an extensive eBook collection.  

Some of our ebooks can't be located through our catalog. For the most comprehensive listing and linking to our books, search by keyword, title, subject or author in these ebook databases:

The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech

Kristian A.  Werling
5th Floor
Call Number: KF1893.B56 F86 2014 

Table of Contents

Chapter 1: Introduction to the Regulation of drugs
Chapter 2: Introduction to the regulation of Medical Devices
Chapter 3: Introduction to the Regulation of Biologics
Chapter 4: Regulation of Industry- Sponsored Clinical Trials
Chapter 5: Key Federal Agencies: Roles and Responsibilities
Chapter 6: Regulation of Advertising, Promotion, and Distribution of Drugs, Medical Devices and Biologics
Chapter 7: Life Sciences: Fraud and Abuse
Chapter 8: Antitrust Issues
Chapter 9: Privacy Issues
Chapter 10: State Regulation
Chapter 11: Intellectual Property
Chapter 12: Payment and Reimbursement Issues
Chapter 13: International Issues
Chapter 14: Life Sciences Transactions and Licensing 

Biotechnology & Nanotechnology Regulation

Biotechnology & Nanotechnology Regulation

By B. David Naidu

Available on Lexis 

Updated November 2016

"Biotechnology & Nanotechnology Regulation authored by David Naidu, analyzes regulation governing biotechnology and nanotechnology industries. Regulation of biotechnology, which generally encompasses the manipulation of living materials by passing genetic information from one organism to another, emerged in the 1970's and is of major concern to the medical, pharmaceutical, chemical manufacturing, and agricultural fields. Nanotechnology, which refers to the design and production of molecular-sized devices and products, is a more recent field whose regulation has an impact on the same industries as biotechnology and also affects semiconductors, communications technology, cosmetics, and consumer products. Additional regulation is quite likely because the need for knowledge of the risks involved in industry processes and products is increasing. Both fields are subject to the same regulatory schemes, and this book describes the application of substantive laws, such as the Federal Food, Drug, and Cosmetic Act, the Clean Water Act, and the Clean Air Act, to each segment of the biotechnology nanotechnology industry. Also discussed are international issues and ongoing development of regulations governing these fields.Features* Examines controversies generated by biotechnology in both the United States and Europe and explains how these controversies will affect the ongoing development of regulation* Regulation of biotechnology and nanotechnology is of major concern to the medical, pharmaceutical, chemical manufacturing, and agricultural fields* The fields of biotechnology and nanotechnology have grown rapidly and are expected to require increased levels of legal services"


Biotechnology & the Law

Biotechnology and the Law

By Iver P. Cooper

Available on Westlaw 

Updated June 2017

"Biotechnology and the Law is a detailed three-volume treatise that shows you how to bring biotechnological inventions in the intellectual property system for protection. The treatise contains complete coverage of the scope of claims, broadening and narrowing of claims, and the working of an invention without undue experimentation and enablement. This database helps you:

  • Understand the issues involved in patenting a biotechnological invention
  • Avoid infringement
  • Learn the significance of the Plant Variety Protection Act and the UPOV
  • Draft claims effectively, clarifying ownership of patent rights
  • Determine adequate disclosure of best mode"




Genetic Data and the Law: A Critical Perspective on Privacy Protection

Genetic Data and the Law:  A Critical Perspective on Privacy Protection

By Mark Taylor

Fifth Floor:  KFNK3611.R43 T39 2012   

"Research using genetic data raises various concerns relating to privacy protection. Many of these concerns can also apply to research that uses other personal data, but not with the same implications for failure. The norms of exclusivity associated with a private life go beyond the current legal concept of personal data to include genetic data that relates to multiple identifiable individuals simultaneously and anonymous data that could be associated with any number of individuals in different, but reasonably foreseeable, contexts. It is the possibilities and implications of association that are significant, and these possibilities can only be assessed if one considers the interpretive potential of data. They are missed if one fixates upon its interpretive pedigree or misunderstands the meaning and significance of identification. This book demonstrates how the public interest in research using genetic data might be reconciled with the public interest in proper privacy protection"

The Regulatory Challenge of Biotechnology: Human Genetics, Food and Patents

The Regulatory Challenge of Biotechnology: Human Genetics, Food and Patents

By Han Somsen

5th Floor: K3925.B56 R444 2007   

"Biotechnology has prompted a revolution in science and society in the truest sense of the word. This book aims to explore ways of designing a regulatory regime that takes heed of different demands whilst, at the same time, answering to the imperatives of effectiveness and efficiency."