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 [...]
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?
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?
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 [...]
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?
If you want to know where the next healthcare revolution will come from, look inside. Physical medicine becomes virtual medicine, becomes mobile healthcare, becomes wearable health and then [...]
Senators Bennet and Hatch reintroduced the Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act, to "cut red tape at the Food and Drug Administration (FDA) and help [...]
FDA approved marketing for 23and Me's Bloom Syndrome Carrier test, months after halting the company's marketing of direct-to-consumer genetic tests. FDA now classifies genetic carrier screening [...]
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 [...]
If you market your healthcare products, FTC enforcement can stop your sales in their tracks. All it takes is a search - yes, good old keywords - and you're in line for significant penalties for [...]
Virtual reality in medicine and health will augment and expand our sense of reality - yet it's only a harbinger of deeper access to consciousness.
The Daily Journal, California's largest legal news provider, published Future of Medicine is Just a Tap Away, by healthcare & FDA attorney Michael H. Cohen.
If you think Obamacare is the most important story in regulation of healthcare, you're missing these key trends that will shape the medicine of 2015 and beyond. Remember that technological [...]
The Federal Trade Commission (FTC) reports that mobile apps need to provide consumers with more disclosures, and also protect the privacy and security of consumer data--thus adding to the [...]
The FDA provides guidance for pharmaceutical and medical device manufacturers as to how to present risk and benefit information for their medical devices and products on social media.
The best way to select a healthcare lawyer or FDA attorney (or FDA regulatory consultant) for legal advice about your health and wellness service, practice, facility, or product, is to follow [...]
The federal appellate decision in U.S. v. Regenerative Sciences, LLC (see Court upholds FDA's legal authority to regulate stem cell therapies) also reflects FDA's evolving legal authority over [...]
FDA survived a legal challenge to its authority to regulate stem cells as drugs, in a landmark decision by the U.S. District Court of Appeals for the DC Circuit. FDA had cited Regenerative [...]
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