Historical, Philosophical, Political and Law Sciences, Culturology and Study of Art. Issues of Theory and Practice. Tambov: Gramota, 2012. № 1. Part 2. P. 198-200.
THE USA FOOD AND MEDICAL PRODUCTS QUALITY REGULATORY AGENCY ROLE IN INNOVATION POLICY SUPPORT IN NEW PHARMACEUTICALS DEVELOPMENT SPHERE
Chaturvedi Anna Adzhaevna, Kapustin Sergei Anatol'evich
Peoples' Friendship University of Russia
Abstract. The authors discuss the activity of The USA Food and Medical Products Quality Regulatory Agency, analyze its functions and powers, contributing to the innovations elaboration in the sphere of pharmaceutical manufacturing and drug development, study the legal questions of the quality preservation of the products produced in pharmaceutical market, and also research the difference between the primary medicinal products and similar medications-generics.
Open the whole article in PDF format. Free PDF-files viewer can be downloaded .
References:
Abraham J. Science, Politics and the Pharmaceutical Industry // Medicine, Society and Industry. 1995. № 2.
Engelberg Alfred B. Special Patent Provisions for Pharmaceuticals: Have They Outlived their Usefulness?: a Political, Legislative and Legal History of U.S. Law and Observations for the Future // The Journal of Law and Technology. 1999. № 39.
Flannery Ellen J., Hutt Barton P. Balancing Competition and Patent Protection in the Drug Industry: the Drug Price Competition and Patent Term Restoration Act of 1984 // Food, Drug, Cosmetic Law Journal. 1985. № 3.
Glasgow Lara J. Stretching the Limits of Intellectual Property Rights: Has the Pharmaceutical Industry Gone Too Far? // The Journal of Law and Technology. 2001. № 2.
Hilts Philipp J. Protecting America's Health: the FDA, Business, and One Hundred Years of Regulation. New York: Knopf, 2003. 394 p.
Merill R. A. The Architecture of Government Regulation of Medical Products // Virginia Law Review. 1996. Vol. 82. № 8. P. 1753-1866.
Roche Products Inc. v. Bolar Pharmaceutical Co. [Elektronnyi resurs]. URL: http://biotech.law.lsu.edu/cases
Shanker Singham A. Competition Policy and the Stimulation of Innovation: TRIPS and the Interface between Competition and Patent Protection in the Pharmaceutical Industry // Brooklyn Journal of International Law. 2000. № 26.
Temin P. Taking Your Medicine: Drug Regulation in the United States. Cambridge: Harvard University Press, 1980.
University of Rochester v. G. D. Searl & Co. [Elektronnyi resurs]. URL: http://www.ll.georgetown.edu/federal/judicial/ fed/opinions/03opinions/03-1304.html
Русский
