Title: Pharmaceutical law : regulation of research, development, and marketing /
Authors: Clark, Michael E., 1956-
Publisher: The American Bar Association, Health Law Section ; BNA Books,
Year: 2007
Subjects: Drug Design; Legislation, Pharmacy; Drug Industry legislation & jurisprudence; Legislation, Drug; Pharmacy Law and legislation United States; Drugs Law and legislation United States; Pharmaceutical industry United States; Drug development United States.; United States
Contents: Statutory and regulatory controls for drug development -- Key federal agencies regulating pharmaceuticals -- Federal regulation of advertising, promotion, and distribution practices -- Potential liability for drug companies, health care providers and insurers: off-label prescribing and internet advertising -- Federal regulation of clinical research -- Avoiding fraud and abuse penalties and sanctions -- Regulation of privacy under HIPAA and other privacy laws -- Federal sentencing guidelines and compliance measures -- The FDA approval process for new drugs -- State regulatory schemes for pharmaceuticals and related issues -- Antitrust and intellectual law issues for pharmaceutical companies -- Securities law issues and disclosure considerations for pharmaceutical companies.