The FDA Provides New Guidance on the “Minimal Manipulation and Homologous Use” of Cell and Tissue Products.

The FDA new guidelines on minimal manipulation include questions and answers. Meeting the minimal manipulation test can save companies a fortune in IND studies and clinical trial tests.


The FDA’s Frequently Asked Questions about the Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) – Part Two

More FDA answers to questions about cannabis-derived CBD drugs, foods, dietary supplements and food products including access to CBD for clinical investigations.


Compliance Issues for Medical Fitness Centers, Gyms, and Wellness Centers – Part 1

As gyms and medical fitness centers expands the services and products they offer and depend more on physician referrals and doctor employment, compliance review becomes a must.


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.


Keys to Navigating Enforcement Risks & Legal Pitfalls When Owning & Operating Your Medical Spa

Many doctors are trying to cash in on the beauty of operating a medical. For some doctors, the attraction is doing work that patients appreciate. Other doctors think the hours are better and that [...]


What Medical Practices Should Know about the Stark Law

The Stark Law is named after California U.S. Congressman, Peter Stark. It seeks to regulate how physicians refer Medicare and Medicaid patients. The law is part of the Omnibus Budget [...]


Should physicians, chiropractors, and other healthcare practitioners worry when they offer coupons for discounts to patients?

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?


An Overview of Legal, Ethical, and Compliance Issues Governing Physician Relationships Doctors Should Know

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 [...]


Navigate the Weird Legal Twists and Turns of Your State’s Telemedicine’s Laws

Telemedicine offers a lot of promise for both physicians and patients. For doctors, it offers another source of revenue – new patients. Telemedicine can mean lower expenses as well because [...]


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.

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