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Tips to Avoid Off-label Promotion

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Dickson Consulting
Dickson Consulting

Presentation addresses legal and regulatory issues associated with off-label promotion of medical devices.

BusinessSanté & Médecine
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Generic Medical Device Company (“Company”) ,[object Object]
Off-Label Usage ,[object Object],[object Object]
InterMune Example of An Off-Label Case ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Schering-Plough Example of An Off-Label Case ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
C ompany Responsibilities ,[object Object],[object Object],[object Object]
Physicians Decisions ,[object Object],[object Object]
Labeling ,[object Object],[object Object],[object Object],[object Object]
Product Nomenclature ,[object Object],[object Object],[object Object]
Indications for Use ,[object Object]
Sales Efforts ,[object Object],[object Object]
Promotional Materials ,[object Object],[object Object]
Promotional Materials Disclaimers ,[object Object],[object Object],[object Object]
Distribution of Journal Articles Or Reference Texts ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Papers ,[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Paper Criteria ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Press Releases ,[object Object],[object Object]
Special Products ,[object Object],[object Object]
Internal Correspondence ,[object Object],[object Object]
Questions and Deviations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Disclaimers ,[object Object],[object Object],[object Object]

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