Can Paying Attention to These Common FDA Mistakes Save Your Healthcare Company from a Plaintiffs’ Lawsuit?

Common FDA mistakes that cause healthcare companies to get sued

How to avoid FDA enforcement by not avoiding FDA in the first place – the top mistake companies typically make when marketing healthcare products

Starting a healthcare company without having prior FDA legal and regulatory review can place your company in serious jeopardy.

Is your therapy an FDA-regulated medical device? How would you know?

Today’s legal strategy sessions involved a healthcare business that is really a healthcare practice in disguise. Let’s look at what legal strategy lessons we can learn here.

Study: Scientifically Unproven Marketing Claims Very Common on Websites

Michael H Cohen has been interviewed by the Medical Ethics Advisor, a well established publication that focuses on current healthcare issues.

Animal dietary supplement manufacturers and distributors beware of FDA warning letters

Animal dietary supplement manufacturers and distributors can run afoul of FDA prohibitions against “drug” claims and receive an FDA warning letter, unless they understand how FDA regulates animal [...]

Dietary supplement legal review could save your company

If you want to sell healthcare products online, the legal hurdles can be steep. 

Will FDA Act if You Link Dietary Supplement Claims to Testimonials or Scientific References?

Can a dietary supplement company link to scientific references that show that that the dietary supplement product is effective in treating a disease such as cancer, diabetes, or hypertension?

FDA is hands-off Low Risk General Wellness Products

FDA has published a Draft Guidance on Low Risk Devices which suggest a hands-off FDA approach to consumer products that are intended for general wellness use, and, present low safety risk

Weight Loss Products FTC Weighs In

You could burn 50 calories just by reading this blog post. Or not. But if you sell a weight loss product with false, deceptive, and misleading claims, you'll burn a lot more calories when the [...]

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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