Pharmaceutical law
Subtitle: regulation of research, development, and marketing
By: editor-in-chief, Michael E. Clark.
Contributors: Clark, Michael E., 1956-
Publisher: Bureau of National Affairs
Published: 2007
Place of publication: Arlington, Va
Language: eng
Number of pages: 853
ISBN-13: 9781570185762
Subjects: Pharmacy -- Law and legislation -- United States; Drugs -- Law and legislation -- United States; Pharmaceutical industry -- United States; Drug development -- United States
Table of contents: title: Statutory and regulatory controls for drug development; title: Key federal agencies regulating pharmaceuticals; title: Federal regulation of advertising, promotion, and distribution practices; title: Potential liability for drug companies, health care providers and insurers : off-label prescribing and internet advertising; title: Federal regulation of clinical research; title: Avoiding fraud and abuse penalties and sanctions; title: Regulation of privacy under HIPAA and other privacy laws; title: Federal sentencing guidelines and compliance measures; title: The FDA approval process for new drugs; title: State regulatory schemes for pharmaceuticals and related issues; title: Antitrust and intellectual law issues for pharmaceutical companies; title: Securities law issues and disclosure considerations for pharmaceutical companies.