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FTC Revised Online Endorsement Guidelines – Part Two

Makers of health care products and health care providers need to understand the FTC guidelines on soliciting endorsements, affiliate marketing, employee endorsements, and permissible testimonials [...]

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FTC Revised Online Endorsement Guidelines

Answers to commonly asked questions about the new Federal Trade Commission (FTC) endorsement guidelines.

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4 Ways to Minimize the Risk of an FDA, FTC or Private Plaintiff, Healthcare Fraud Label When Marketing Healthcare Products

Whenever you market a healthcare product, beware of potential FDA and FTC enforcement as well as private plaintiffs who can sue for false advertising, unfair competition, deceptive and misleading [...]

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How are home health kits regulated under FDA and state law?

If you've designed a home health kit to test for, say, pregnancy or HIV, can you go ahead and market the product without FDA clearance or state law authorization? FDA regulates some health test [...]

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Daily Journal Publishes “FDA’s General Wellness Guidance is Welcome News”

The Daily Journal published FDA’s General Wellness Guidance is Welcome News by healthcare and FDA lawyer Michael H. Cohen. The article (Cohen.P.0129) goes through FDA's general wellness guidance [...]

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How to Piss Off the FTC After Offending the FDA

If you want to know how not to offend the FDA and FTC sequentially, here's an instructive lesson about a company that has gotten a big regulatory bruise.

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Does the FDA Regulate Mobile Apps Designed for Health and Wellness?

Health and wellness mobile apps and online programs raise a variety of legal and regulatory issues that require legal expertise in structuring a health education or healthcare products or [...]