Cooper, Iver P. Biotechnology and the Law. Eagan, MN : Thomson West, 2002- [KF133.B56 C66 (2023 Update)] [Available electronically via Westlaw to UNC Law Students and Faculty (2024 Update)].
This treatise helps practitioners understand the use issues involved in patenting biotechnological inventions; how to: avoid infringement, draft claims efficiently, clarify ownership of biotechnology patent rights, learn the significance of the Plant Variety Protection Act and the International Union for the Protection of New Varieties of Plants.
Dixon, Marden G. et al. Drug Product Liability. New York, NY : Matthew Bender & Company, 1974- (2024 Update) [Available electronically via Lexis Advance to UNC Law Students and Faculty].
This treatise offers a detailed analysis of litigation involving many of today's frequently prescribed drugs and medical devices. In this treatise you'll find an in-depth discussion of the unique responsibility of each party --manufacture, physician, hospital, nurse, and pharmacist -- and valuable perspective you can apply to your case.
O'Reilly, James T. and Van Tassel, Katharine A. Food and Drug Administration. 4th ed. St. Paul, MN : Thomson Reuters, 1947- (2023 Update) [KF3871 .O71] [Available electronically via Westlaw to UNC Law Students and Faculty].
This treatise was designed to assist the corporate practitioner in providing preventive and defensive advice on Food and Drug Administration law to the firm, its operating employees, and its accountable management.
Thomas, John R. Pharmaceutical Patent Law. 3rd ed. Arlington, VA : Bloomberg BNA, 1967- [KF3133.D78 T46 (2018 Update)] [Available electronically via Bloomberg Law to UNC Law Students and Faculty (2020 Update)].
This treatise takes on the complicated tasks of tracking legal developments within the Patent and Trademark Office, the Federal Drug Administration (FDA), Congress, the courts, the Federal Trade Commission (FTC), the Department of Justice, and the World Trade Organization; examining how these agencies and organizations interact with each other; and determining how they impact strategies within a practitioner's core area of expertise.
Pharmaceutical and Medical Device Law : Regulation of Research, Development, and Marketing. 2nd ed. Michael E. Clark, editor-in-chief. Arlington, VA : Bloomberg BNA, 2015 (2018 Update) [Available electronically via Bloomberg Law to UNC Law Students and Faculty].
This treatise addresses the statutory and regulatory controls for drug development, advertising, promotion, and distribution. It also addresses potential liability for drug companies, health care providers, and insurers.