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Products Liability, Advertising and Promotion, Warnings and Labels, Series: Ask an Expert, Off Label Promotion, For Entrepreneurs

Products Liability Risks of Medtech Websites


Question: What are the regulatory and products liability risks associated with medtech companies' websites and online activities? Answer: To be a viable going concern today, it is...

5 minute read
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Series: Ask an Expert, Off Label Promotion, Claims and Litigation

FDA Prosecution under the Park Doctrine


Question:What is the Park Doctrine and how is the FDA using it to criminally prosecute corporate officers of life sciences companies? Answer: Following heavy-handed rhetoric by...

2 minute read
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Risk Management, Sales Reps, Warnings and Labels, Series: Ask an Expert, Off Label Promotion

Off-Label Promotion


Question:What risk management precautions should a firm take if significant sales are derived from off-label use of its drug or device? Answer: Promoting medical devices and...

4 minute read
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Distributors, Sales Reps, Series: Ask an Expert, Off Label Promotion

Manufacturer Contact with Patients


Question:What should life sciences manufacturers do if contacted by patients? How much information can the manufacturer pass along, if any? Answer: When responding to a patient...

4 minute read
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