Dietary Supplements – Strategies to Reduce FDA Risk
Because marketing and distributing dietary supplements carries FDA risk, we offer sample strategies to reduce FDA risk when selling dietary supplements.
How will FDA regulate predictive clinical software as predictive analytics pushes medical frontiers?
Predictive analytics will push the frontiers of clinical care; the question is whether FDA regulation will promote or stifle innovation in the name of consumer protection.
Is personalized medicine future healthcare?
No sooner had the ink dried on my post, Telemedicine: The Medicine of the Future, than some blogger pronounced telemedicine the "medicine of the past." There, by a stroke of the pen, someone [...]
Michael H Cohen Speaks on MHealth & Wearable Health Technology: Will FDA Legal Compliance Stymie or Promote Innovation
Healthcare & FDA lawyer Michael H Cohen speaks on MHealth & Wearable Health Technology: Will FDA Legal Compliance Stymie or Promote Innovation, at the Health Law Section of the Los Angeles County [...]
FDA cosmetics regulatory power enhanced by proposed Personal Care Products Safety Act
FDA would have significantly greater authority over cosmetic products under the Personal Care Products Safety Act. The Personal Care Products Safety Act would increase regulation over many [...]
Federal bill to boost health IT innovation by exempting low-risk medical software and mobile apps from FDA regulation
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 Approves 23andMe’s DNA Personal Genome Test for Bloom Syndrome Carrier
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 [...]
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Herbal Supplements Investigated for Misbranding and Adulteration
New York's Attorney General initiated the investigation against major retailers of herbal supplements, based on DNA testing of plant materials suggesting contaminants, and mislabeling; was the [...]
Daily Journal Publishes “FDA’s General Wellness Guidance is Welcome News”
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 [...]
9 Keys to Managing Risk of FTC enforcement (especially with anti-aging and weight loss claims)
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 [...]
