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.
More FDA answers to questions about cannabis-derived CBD drugs, foods, dietary supplements and food products including access to CBD for clinical investigations.
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.
Starting a healthcare company without having prior FDA legal and regulatory review can place your company in serious jeopardy.
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 [...]
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 [...]
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?
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 [...]
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 [...]
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.
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 [...]
Many aspects of healthcare are now becoming integrated. Medical practices that used to specialize are now trying to broaden their services by contracting with other medical providers who provide [...]
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 [...]
Healthcare providers who move beyond a brick-and-mortar physical practice often find themselves in a legal gray zone, wondering whether they are compliant, or even what rules might apply. This [...]
Our guest post this month is from Siegfried Othmer, Chief Scientist of the EEG Institute and President of the Brian Othmer Foundation, challenging this year’s FTC “brain training” enforcement.
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 [...]
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 [...]
A benevolent AI (artificial intelligence) could usher in utopia... but will augmented intelligence destroy it?
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