SORT BY Relevancy
Nathan Cortez, JD co-wrote an article on FDA regulation of mobile apps published in the July 24, 2014 issue of NEJM. Luckily, we snagged an opportunity to interview him - you can listen here.
We covered a wide variety of topics including:
Why regulate mHealth anyway?
The new FDA guidance — what needs to be regulated and what does not?
How does the FDA handle at continual updates of mobile health products – so different from the pharmaceuticals that they regulate? How do they decide whether an update constitutes a major change, requiring re-review and one that is minor and does not?
What is “substantially equivalence” and how is it being used in mHealth
How does the FDA handle mHealth products that provide consumer decision support (CDS)? What is the difference between low risk and high risk CDS?
Does the FDA have the right people/processes in place to provide oversight of mHealth?
Professor Cortez teaches and writes in the areas of health law, administrative law, and FDA law. His research focuses on emerging markets in health care and biotechnology. Prof. Cortez has become one of the world’s leading legal scholars on medical tourism, patient mobility, and cross-border health insurance, and has published several articles and book chapters on the legal and ethical implications of these phenomena. His research also addresses mobile health technologies, how to regulate innovations that disrupt static regulatory regimes, the First Amendment restraints on FDA regulation (including FDA's graphic tobacco warnings), immigration federalism, and alternative modes of regulation.
The proposed rule, which is part of the Food Safety Modernization Act, would tighten regulations on pet food and animal feed "by requiring animal food facilities to take preventive steps to ensure that food for animals is safe," according to the FDA.
The controversy surrounds the rule's effect on the longtime practice of beer brewers giving their spent grain, the malted barley left over after the beer brewing process, to neighboring ranchers and dairy farmers. The practice serves two purposes: to help the brewers get rid of millions of tons of leftover product, and to provide a free, nutritious food source for animals at local farms.
Under the new regulation, the practice would be outlawed, unless breweries go through expensive and time-consuming measures to ensure the grain is up to regulation.
"The proposal is part of the Food Safety Modernization Act's larger effort to modernize the food safety system for the 21st century and focus public and private efforts on preventing food safety problems, rather than relying primarily on responding to problems after the fact," wrote the FDA in a press release.
This week we speak with Paul Voss about his article for IEEE Spectrum on Sensible Small Drone Regulation. We also talk to Terry and Belinda Kilby about their book Drone Art Baltimore. Lots to talk about with the Amazon First Air and a pletora. Lots to discuss with the Amazon PrimeAir and a plethora of news interviews to review.
Dr. Kevin Passero and his special guests Dr. Tracy Hackett and Dr. Shaundel Knights of Eastern Holistic Arts will be discussing weight management, digestive health regulation through natural medicine, and types of healing massage treatments.
Tracy L. Hackett, DOM, L.Ac, is a Licensed Acupuncturist and clinical herbalist in Washington, DC. Dr. Hackett has practiced Traditional Chinese Medicine (TCM) since 2005 and has been teaching yoga and meditation since 1997. Her study of healing arts in India, China, Ladakh, Nepal, Thailand, and Bali gives her a well-rounded cultural understanding of traditional medicine and healing modalities.
Dr. Shaundel Knights, ND, grew up in Guyana, South America and knew she would follow in the footsteps of her grandmother, a natural healer. Today she is a naturopathic physician with a focus on natural skin care and pain management. Dr. Knights is also a certified massage therapist and maintains this hands-on approach to healing in her practice.
Masaccio is the nom de blog for Ed Walker, former Securities Commisioner for the State of Tennessee. He and Jay Ackroyd discuss the nature of markets and their role in a mixed economy. "Market solutions" have become an objective for policy makers, both conservative and centrists,which is entirely wrong. Markets are policy tools,not policy goals.Moreover,there are no "free markets." Markets can only arise within a framework of complex regulation. There is no more regulated marketplace than securities markets.
One of a series of exporations of income inequality, economics and public policy, the 1%, plutocracy, income distribution, wealth distribution
Follow @MasaccioFDL @JayAckroyd
Regulation in the Internet Age
Libertarians Unleashed V5N37
Has the paradigm shifted from having government check out every business for safety?
Do we need building codes?
Could individuals manage their own relationships with the commercial sector?
How dos the Internet affect that?
DON'T BE ENTANGLED IN THE CARES OF THIS WORLD!
QUANTUM ENTANGLEMENT THEORY
RULES; REGULATIONS AND RITUALS
The Ultimate tool of Babylon, Baal, Skalas, Samael is the power of fear of hell, to drive the people into a false conversion that leads to “submission to Godly authority based on religious tradition”.
This is the greatest social and political brainwashing tool of all time! "They" destroyed the teachings of the True Messiah and replaced it with RULES, REGULATIONS AND RITUALS of the Babylonian Mystery school,
called Orthodox __________you fill in the blank!
Everything you love of the material existence drags you down into the darkness, because you become entangled with it by your Intentions or Love. If you love self or things more than others, your entanglement is with yourself, and is a magnetic vortex of increasing hardness and density.
Our first show of 2014 and marking a year of webcasts presents multi-award-winning heavy metal drummer Jason Bittner (Shadows Fall, Anthrax) ... Nashville's own Regulation Nine and British rockers Boardwalk Isabella! PLUS Cindy D'Adamo of Ladylake Music holds 'Rockstar 101' class.
Click "Follow" on our BlogTalkRadio page to get the news first!
And be sure to leave us your comments, questions and tell us who you'd like to hear on the show in 2014!
Also order your OFFICIAL TheDavidBowersAwards T-shirts on our website at www.thedavidbowers.com !
in Self Help
Well, if it isn't time for my weekly 3 hour break from my TBI to my TBI, and how I enjoy talking to you folks! Its my 'break' from the 'scene', if you will. My scene? Past few months it been situated in my bed room or inside the Downtown Milton Studio. Emotional wreck? Far from it, even in the midst of this winter. Emotionally mad about staying inside? Not really, its cold. Emotionally happy? On Sundays and in prep for the show usually. How about Emotionally stuck in a family situation, confused. You know, like deciding what T.V. show to watch, which can be confusing to the mind, before just deciding not to watch anything. I KNOW HOW YOUR LIFE GOES - SO DOES MINE. Yet, pretty well trained by the Dr. Lisa Thompson Foundation Center to regulate my personal stimuli - the process doesn't ALWAYS work in controlling your emotions. But helps. Helps all - Survivor, Family, Caregiver, everyone - even the postal workers (let's hope). Julie Sharp-Kintz will again be on the show, as we discuss Emotional Regulation with you. Call us. Julie, in her final semester in Phsycology at IPFW University, has spent the weekend researching our subject. Except for phone time with me - because we need her on Brain Injury Radio and I 'discussed' (rambled) the subject. What an inspiration. And she says she can be Emotionally bored? Uh, Co-Host's, Kelly, all - that's my primary job on TMDS. Speaking of CoHost's, Jasmine will (hopefully) reflect on her first 'On The Road" experience across America (Greyhound has been an Emotional wreck for her). Call us, let's get Emotional with another.(424)243-9540 or new Toll Free #'s (855) 473-3711. Outside North America (the Islands & Panama Canal on up, I reckon) our Free Number is (202) 559-7907. No Lefty, no cat #.
President Obama, in a typical Obama like move has asked the FCC to re-classify the internet as a utility. This would allow the FCC to regulate it more fully. Why is the president interested in controlling the internet? Why does he care about it so very much? Well listen in today and find out.
UNREDACTED with Rachel Marsden: Lifting the black ink to reveal the covert information and intelligence around global events.
Details about today's guests: www.unredactedshow.com/vault.html
Show website: www.unredactedshow.com
An essential oil is a concentrated hydrophobic liquid containing volatile aroma compounds from plants. Essential oils are also known as volatile oils, ethereal oils, aetherolea, or simply as the "oil of" the plant from which they were extracted, such as oil of clove. An oil is "essential" in the sense that it carries a distinctive scent, or essence, of the plant.Essential oils do not form a distinctive category for any medical, pharmacological, or culinary purpose. They are not essential for health.
Essential oils are generally extracted by distillation, often by using steam. Other processes include expression or solvent extraction. They are used in perfumes, cosmetics, soaps and other products, for flavoring food and drink, and for adding scents to incense and household cleaning products.
Essential oils have been used medicinally in history. Medical applications proposed by those who sell medicinal oils range from skin treatments to remedies for cancer and often are based solely on historical accounts of use of essential oils for these purposes. Claims for the efficacy of medical treatments, and treatment of cancers in particular, are now subject to regulation in most countries.As the use of essential oils has declined in evidence-based medicine, one must consult older textbooks for much information on their use.
Interest in essential oils has revived in recent decades with the popularity of aromatherapy, a branch of alternative medicine that claims that essential oils and other aromatic compounds have curative effects. Oils are volatilized or diluted in a carrier oil and used in massage, diffused in the air by a nebulizer, heated over a candle flame, or burned as incense.http://en.wikipedia.org/wiki/Essential_oil.
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