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Books
Pharmaceutical law : regulation of research, development, and marketing
- Available as
- Physical
Details
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- Creator
- editor-in-chief, Michael E. Clark
- Format
- Books
- Language
- English
- Contributors
- Publication
-
- Arlington, Va : American Bar Association, Health Law Section : BNA Books, [2007]
- ©2007
- Physical Details
-
- xlvi, 853 pages ; 27 cm
- ISBNs
- 157018576X, 9781570185762
- OCLC
- ocn163813083
- Includes bibliographical references and indexes.
- 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
Subjects
- Pharmacy -- Law and legislation -- United States.
- Drugs -- Law and legislation -- United States.
- Pharmaceutical industry -- United States.
- Drug development -- United States.
- Legislation, Drug -- United States.
Medical Subject Heading
- Drug Industry -- legislation & jurisprudence -- United States.
Medical Subject Heading
- Legislation, Pharmacy -- United States.
Medical Subject Heading
- Drug Design -- United States.
Medical Subject Heading