Biotechnology: Law, Business, and Regulation
Biotechnology: Law, Business, and Regulation offers comprehensive analysis on the advancement of a biotech discovery into a commercial product, making it easy for you to identify legal issues as they arise in the R & D and commercialization process; anticipate forthcoming legal and regulatory challenges; and develop an effective strategy for efficient commercialization. Real product and industry examples are used throughout the handbook and pending legislation is discussed and analyzed. This is the first book to pull together all the legal issues associated with the burgeoning biotechnology industry. The author explains and analyzes the current dimensions of biotechnology law, with in-depth attention to: the markets for biotech products
-- patent protection
-- confidentiality and other intellectual property issues
-- government-supported cooperative R & D agreements
-- corporate securities issues
-- clinical trial agreements, including informed consent, liability, and insurance issues
-- FDA regulation and tracks to speed product approval and commercialization
-- legal implications of foreign R & D
-- public health and policy considerations
-- legislation prohibiting discrimination on the basis of genetic information
-- and ethical norms of the scientific and medical communities.
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