Pharmaceutical law : regulation of research, development, and marketing / editor-in-chief, Michael E. Clark.

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
The regulation of biologics.