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.
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.
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?
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 [...]
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Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, and issuing its new draft Guidance on [...]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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
The FDA issued a warning letter citing a dietary supplement company for its online content.In its warning letter to dietary supplement manufacturer M.D.R. Fitness Corp., the FDA warned that [...]
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