Dietary supplement legal review could save your company
If you want to sell healthcare products online, the legal hurdles can be steep.
“The Doctor Weighs In” Features Interview on FDA Mobile Medical App Regulation
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 [...]
Dietary Supplements, Cosmetics, Medical Devices – Why Substantiating Claims Matters
Substantiating claims matters whenever you bring a dietary supplement, cosmetic (or skin care product), or medical device to market - why?
Digital health personalizes medicine, revolutionizes healthcare, and makes healthcare law anachronistic
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.
4 Ways to Minimize the Risk of an FDA, FTC or Private Plaintiff, Healthcare Fraud Label When Marketing Healthcare Products
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 [...]
FTC Slams Fat Burning, Calorie-Blocking and Body Slimming Marketing
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.......
Which disruptive healthcare innovations will push medical frontiers in the next 5 years?
Pundits prognosticate, but how do we measure a future for healthcare when every trend morphs asymptotically?
The Next Healthcare Revolution is Inside You: Wearable Health Tech Legal & Regulatory Issues Will Astound Us
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 [...]
If your medical device requires FDA 510k clearance but you put it on the market without a 510k, what happens?
If your medical device requires FDA 510k clearance but you put it on the market without a 510k, what happens?Many clients have asked us: do we have a medical device? Do we need to submit a 510k? [...]
How are home health kits regulated under FDA and state law?
If you've designed a home health kit to test for, say, pregnancy or HIV, can you go ahead and market the product without FDA clearance or state law authorization? FDA regulates some health test [...]
