Pharmaceutical law regulation of research, development, and marketing

Statutory and regulatory controls for drug developmentKey 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 adverti...

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Bibliographische Detailangaben
Körperschaft: American Bar Association Health Law Section (BerichterstatterIn)
Weitere Verfasser: Clark, Michael E. (BerichterstatterIn)
Format: UnknownFormat
Sprache:eng
Veröffentlicht: Arlington, Va. BNA Books c2007
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Beschreibung
Zusammenfassung:Statutory and regulatory controls for drug developmentKey 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.
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.
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
Beschreibung:XLVI, 853 S.
ISBN:9781570185762
978-1-57018-576-2