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.
Scott Tips, president and legal counsel for the National Health Federation (NHF), will tell us how harmonized global standards are enabling overall reduced vitamin and mineral levels in pill and food form. In February, the U.S. Food and Drug Administration (FDA) proposed changes to both the current Nutrition Facts panel on food labels and Supplement Facts panel on dietary supplement labels that prompt concern.
“While the food industry, media and general public focus on the proposed format changes, new wording and label design, there’s a danger to our health in the FDA harmonizing our Reference Daily Intake (RDI) of vitamin and mineral levels down to the extremely low levels of the Codex Alimentarius, which our organization has fought against for more than a decade,” advises Tips.
If the proposed rulemaking is adopted, the NHF anticipates that the FDA will work to conform other recommended nutrient values to those of Codex. Support for this projection is based on an October 11, 1995, FDA pronouncement in the Federal Register to harmonize its food laws with those of the rest of the world.
Voice your concerns NOW before it's too late. Write to the FDA at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5360 Fishers Lane, Rm. 1061, Rockville, MD 20852. Mention Docket No. FDA-2012-N-1210, to insist that the FDA cease pushing its harmonization agenda. For more information, visit Tinyurl.com/NHFCaseForNutrients.
[LS2]Took out extended. Things have changed FDA recalled their extended deadline for emails. Now have to write comments to the address supplied. Took out URL
Army Wife Talk Radio is the leading internet talk radio show for Army wives, by Army wives. AWTR is hosted by the Army Wife Network Core Team - www.ArmyWifeNetwork.com. AWTR guests bring exciting, relevant topics and resources to the attention of our military families.
Guest: Kameryn Futral - Inside Combat Rescue
Join us for our pro talk segment on Sports With The StatMan on Wednesday night.
In baseball, we recap the Trading Deadline after a wild flurry of trades on Deadline Day. The Red Sox dismantled their 2014 team and re-tooled for 2015. The Yankees made a couple of low-key acquisitions, while the Mets and Phillies did nothing to improve their teams for the future. But, sometimes, the best deals are the deals you don't make. We will also follow the pennant races and give our take on the big issues around baseball from the local teams and around the league.
We will debut our 2014 pro football coverage with the start of our 2014 StatMan NFL Preview, where we take a division-by-division look at the upcoming season. All of the comings and goings, camp battles, what to watch for, and the big questions with each team. We will also pick each regular season game for each team and give you our predictions. First up is the NFC West, including the defending Super Bowl Champions, the Seattle Seahawks, and the AFC West
Listen live this Wednesday night at 11pm ET or download the podcast here. "Like" the show on Facebook. Follow the show on Twitter (@gstatman) for the latest updates. You can also download the show on iTunes from your PC or mobile device in the iTunes Store, as well as Stitcher. And, the Random Musings blog is always on.
On today's episode of Getting Social with Miriam, Yvette Vega will be interviewed. Yvette Vega, Executive Producer for the Endorphins System,has released a program to help people suffering from depression to regain control of their lives.Ms. Vega is also Director of Public Relations for Neurobehavioral Research; an FDA approved Clinical Research site. After what happened with Robin Williams, the topic of depression needs to be brought out more.
Topic: Plastic Surgeon Non Surgical Face Lift and ML 830 Laser
Guest: Dr. Daniel Man M.D
Host: Mike Barbour
Take a 90 Day Test Drive:
Prices starting under $3000
1-888-658-3094, ext 101
#BGEPresents with host @jiggyjaguar
Maria Sanchez- Expert on Current News and Politics
"Be Aware of What You Eat"
The Food and Drug Administration today took a step toward potentially eliminating trans fats from the food supply with a preliminary determination they are no longer "generally recognized as safe."
Maria Sanchez talks about the effects of trans fat, where to find them, and also why the FDA has taken action to eliminate this fat.
Dr Stanislaw R. Burzynski, M.D., Ph.D has a mission to beat cancer. For over 35 years, Dr. Burzynski has led cancer research and care through his Burzynski Clinic, inspired by the philosophy of the physician Hippocrates, to, "First, do no harm." He also fought and won the largest legal battle against the Food & Drug Administration (FDA) in American history.
Since 1967, Dr Burzynski - an internationally recognised physician and biochemist-researcher - has pioneered the development and use of biologically active peptides (Antineoplastons), in diagnosing, preventing and treating cancer, with much controversy along the way. Dr Burzynski’s approach to treatments are based on the natural biochemical defence system of our body, capable of combating cancer with minimal impact on healthy cells.
Despite multiple attacks on his work over more than a decade, including 5 Federal Grand Juries attempting to indict him, the unavoidable fact still remains: Antineoplastons are responsible for curing some of the most “incurable” forms of terminal cancer.
Join Brendan D. Murphy and Aimee Devlin in this episode of Global Freedom Movement Radio, as they speak with Dr Burzynski, to learn why the FDA and Big Pharma are doing everything they can to stop Dr Burzynski in his tracks; and special guest Shontelle Hiron, a former Australian patient of Dr Burzynski’s, diagnosed with brain cancer and given only weeks to live by Oncologists in 1993. Her only treatment for brain cancer has been Antineoplastons. She is still with us today.
Topic: Infrared or Dead Patient Tells His Story
Host: Mike Barbour
Take a 90 Day Test Drive:
Prices starting under $3000
1-888-658-3094, ext 101
Read more: http://www.blogtalkradio.com/coldlasertoday/2014/08/08/infrared-or-dead-patient-writes-book-on-the-ml830-cold-laser#ixzz3AobkDJeP
Do you have high blood pressure?
Do you or your child have ADHD?
Are you unsure about the drugs you're taking?
Today's guest is Dr. George Grant.
was a senior consultant for Health Canada, the FDA, & the CDC
is a renowned Pharmaceutical Toxicologist
is an expert in Bio-Feedback, stress relief, & anti-aging
is the author of, Your 101 Ways to Your 101
is considered, Canada's Wellness Ambassador
For more info on Dr. Grant visit: www.academyofwellness.com
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