Archives

The healthcare industry is a complicated, multi-trillion-dollar gargantuan and require that a healthcare law firm deploy its specialized knowledge across multiple domains.

The legalization of many CBD oil products has opened the door to many new business opportunities. It is critical to review how each product is manufactured, classified, branded, marketed, and [...]

Learn how to avoid these FDA legal traps when marketing your dietary supplement product.

Your dietary supplement products could be regulated as a new drug by FDA, unless you pay attention to these regulatory fundamentals.

As they say in Game of Thrones, “Winter is Coming.” It’s a grim statement that reminds everyone that ahead is nothing but snow and ice. When you’re preparing to launch your dietary supplement [...]

Many of our dietary supplement companies come to us with various mistaken assumptions with respect to labeling their dietary supplement products. Let’s talk about 5 key dietary supplement [...]

Cosmetic products do not require Food and Drug Administration (FDA) approval unless they have color additives or unless the qualify as a drug, medical device, or dietary supplements. There are [...]

Naturally, like any other business model, augmenting one’s clientele may be a priority for medical and other healthcare practitioners. Is it legal to offer coupons and discounts?

Physicians regularly work with businesses who want the doctors to use their products. To encourage physicians to choose their practice over competitor practices, vendors often offer incentives. [...]

Doctors need to understand the laws and regulations that apply to the way they bill for services, work with insurance companies, submit claims to the government, enter into business relationships [...]

FDA labeling is one of the most important regulatory requirements for dietary supplements in that it provides the consumer the necessary information on the product. Indeed, ensuring that all [...]

The first step in evaluating how laws impact veterinary medicine is to understand what telemedicine means. Telemedicine during veterinary practice (also known as tele-veterinary practice) can [...]

Physicians, chiropractors, and other healthcare licensees often want to function as “health coaches” and avoid thorny laws. Can they?

A California investigation and disciplinary action against a California naturopathic doctors suggests how physicians can incur legal jeopardy when operating a medical spa, holistic healthcare [...]

Naturally, like any other business model, augmenting one’s clientele may be a priority for medical and other healthcare practitioners. Is it legal to offer coupons and discounts?

Physicians who incorporate complementary and alternative medical (CAM) modalities into their practice, or brand themselves as using integrative medicine, functional medicine, or similar [...]

FDA is changing the playing field by withdrawing its earlier Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, and issuing its new draft Guidance on [...]

THE LAW HANDLES TELEMEDICINE PRESCRIPTION DIFFERENTLY THAN DIAGNOSING AND TREATING REMOTELY. HOW CAN YOU BEST COMPLY? PRESCRIBING IS DIFFERENT THAN OTHER TREATMENT

While recent legal developments have loosened legal strictures around truthful, non-misleading, off-label promotion of drugs, there are legal limits to an off-label promotion strategy. Here [...]

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 [...]

Is it illegal for audiologists to dispense PSAPs? More broadly – are disruptive technologies also exploding healthcare professionals’ ability to prescribe or recommend to their patients? I [...]

Avoid these common FDA mistakes marketing health products: communicating with FDA without legal counsel, making disease claims, misunderstanding the rules.

For an OTC drug marketing legal checklist, 5 legal strategy steps can propel you to market.

Is there a Moore's law for law? Can healthcare and FDA laws regulate convergent, exponential technologies?

Cosmetic or drug? Claims matter for body sculpting and slimming products, and all health and wellness products.

According to FDA medical device guidance - substantial equivalence in the 510(k) premarket notification process can be clearly determined if you know the underlying legal rules. One of the [...]

FDA's tobacco products deeming rule hits companies with many compliance obligations for both existing tobacco products and new products "deemed" to be subject to FDA jurisdiction. This is a [...]

If you are a retailer, manufacturer, distributor, or importer of tobacco products, become familiar with the final rule by FDA Deeming Tobacco Products to be Subject to the Federal Food, Drug, and [...]

Digital health advances set healthcare law on edge because health tech develops exponentially while laws grow linearly.

Is my app an FDA-regulated medical device? That depends, in part, on whether it makes medical claims and whether the app itself, in FDA's view, diagnoses and treats disease.

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

Blogger Patricia Salber, MD MBA featured Understanding whether a medical app needs FDA regulation can be tricky on The Doctor Weighs In. In this videotaped interview, held at the 2015 Stanford [...]

Substantiating claims matters whenever you bring a dietary supplement, cosmetic (or skin care product), or medical device to market - why?

By putting healthcare in the hands of patients, healthcare technology is not only revolutionizing the way we think about medicine, but also the way laws shape personal health.

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 [...]

Would you like to lose weight without diet or exercise, by a magical fat-burning, calorie-busting, body-slimming dietary supplement or cream? Here's how.......