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Investigational Drugs And The Law, George F. Archambault

Cleveland State Law Review

Moving directly to the subject "Investigational Drugs and the Law" and being concerned primarily with preventative law, a topic not unlike preventative medicine, what is it that must be known as a lawyer in this specialty field in order to aid physicians and pharmacists involved in clinical research, in clinical pharmacology research, in hospital administration, and in nursing and pharmacy practices to keep them from legal pitfalls? It is necessary to tackle the subject in a two-pronged manner: (1) the federal and state statutes, and (2) case law.