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Life sciences law is a broadly-defined, umbrella term encompassing a wide array of scientific discovery, policy judgment, and legal issues that affect the development, production, distribution, and use of pharmaceuticals, biotechnology products, and medical devices. Other relevant areas include food, dietary supplements, crop technology, animal husbandry, and other aspects of sustenance, health, or productivity of man and animals. In each case, important underlying considerations are taken into account including, safety, effectiveness, societal need, cost, environmental impact, and technological evolution.
Legal practice in the life sciences area demands current and historical knowledge about relevant laws and regulatory entities, direct or consultative expertise in scientific methodology and data development, understanding the disciplines such as risk assessment and good manufacturing practice, and more. Legal services in the area may involve regulatory consulting, compliance review and advice, intellectual property and technology management, privacy law counseling, licensing and contracting expertise, business advice, financial investment, supply chain management, etc.
Issues confronted by attorneys practicing in the field of Life Sciences Law include:
The field within Health Care Law that concentrates on “Life Sciences” includes the following subjects:
This sub-area of Health Law involves the interpretation and application of the following:
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