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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.
WERE BACK ON TONIGHT AT 7:00 PM CALI TIME 10PM EASTCOAST TIME.BRINGING U ANOTHER HOT SHOW WITH ARE HOST JACK "MONSTER " JOJOLA AND ANGELA GSB MORALOS, AND ELLEN COSS KENNEDY. WE WILL BE SPEAKING ABOUT THE TOP DOGG MAGAZINE AND WHAT ITS ALL ABOUT .ALONG WITH SOME OF THE UPCOMING SHOWS HITTING YOUR STATE.JOIN IN ON THE CONVO ITS GOING TO BE HOTT!!!!!!!
WERE BACK ON TONIGHT AT 8:00 PM CALI TIME .BRINGING U ANOTHER HOT SHOW WITH ARE HOST JACK "MONSTER " JOJOLA AND ANGELA GSB MORALOS. WE WILL BE SPEAKING ABOUT THE TOP DOGG MAGAZINE AND WHAT ITS ALL ABOUT .ALONG WITH SOME OF THE UPCOMING SHOWS HITTING YOUR STATE.JOIN IN ON THE CONVO ITS GOING TO BE HOTT!!!!!!!
Join Host, Ozwald Balfour and Guests for a Spirited Discussion on The TRUTH About Government and the Law in America.
The Judicial Branch of Government is the Most Corrupt and Out of Control. Judges, Prosecutors and Attorneys Are All Members of the Same Private, Members Only Club That Has High Jacked COMMON LAW and Perverted the Ways of JUSTICE in America.
You Are Invited to CALL THE SHOW and SHARE Your Experiences.To Make A Difference, YOU MUST BE DIFFERENT. Learn How Find the Best Lawyers Such as Edward Flint. More Importantly, Educate Yourself and Defended Your RIGHTS In Propria Persona.
Luke: 11:52 “WOE UNTO YOU, LAWYERS! FOR YOU HAVE TAKEN WAY THE KEY OF KNOWLEDGE:…”
It's Saturday Night! and time for the Salo and Hutch Show!!What a better way to spend your night than listening to a couple for guys who talk about every day teen stuff.You know, you might even lean some new things.I think their new CD is still in the works, so we will have to see what progress they have made.Stay Safe ,and Be Cool!
Guest Commissioner Chris Monzel, host, panelists Cindy Todd, James Neighbors, Kelly Mordecai, with Dan. Call in and you stay on the line. You too can Join our Round Table Discussion. Follow the Show to get email messages for upcoming episodes. Just hit the follow button of this Link http://www.blogtalkradio.com/bards-logic-political-talk
These topics have local and national interest for our listeners. Water/sewer ratepayers will continue to see year-over-year increases in sewer rates to pay for EPA mandated improvements to the system. For many communities, this can be a significant long-term burden. The 1/4 percent sales tax proposal for the repair of Union Terminal/ Museum Center that will be decided by voters. What are the primary responsibilities of county government and what has Hamilton County done to achieve the goal of right-sizing county government.
Chris Monzel began 2014 leading the charge for fiscal responsibility and efficient County government. His first term has presented a series of economic challenges as well as opportunities that required skilled leadership. Chris has been instrumental in cutting red-tape for business expansion and relocation as well as holding a tight line on department budgets while directing oversight of mandated upgrades to the Municipal Sewer District. As commission president, Chris also serves as President of the Emergency Management Agency, is a member of the Transportation Improvement District, Investment Advisory Committee, Storm Water District Oversight Board and both the Executive Board and Region Workforce Investment Board. He has been a Designated a Six Sigma Black Belt recipient.
Learn more about Chris Monzel at Monzel.com, Follow him on Twitter @VoteMonzel or Like his page on Facebook at Chris Monzel for Hamilton County Commissioner
Is the United States Worth Saving? That is the question we will attempt to answer every Wednesday at 4 PM Pacific/7PM Eastern. So join host of "The Ignorance Equation", Nick Katsouros, and author Charles W. Thompson, as we discuss what each of us must do to fix our broken country.
Open Forum show, ALL opinions welcomed.
This week we will talk a little bit about the Golden Age of Government, and the impact great Government policies had on improving people's everyday lives.
Not Enough? Need More?
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What happens when you are set up to take the fall for someone with connections in the US intelligence community? How far does the influence of such a person reach? James Faller knows better than anyone. He has been the victim of repeated malicious prosecutions by the Justice Department, the IRS and two state governments. His story will shock you and educate you about the degree to which those who serve the interests of the international elite are given a free pass to commit crimes and to destroy the lives of anyone who tries to expose them.
This explosive story and its ramifications are so convoluted and involved that it will take several hours to fully explore. This interview with James Faller is the first of a series.
This show will be rebroadcast on September 27 at 9 AM PST/ 12 PM EST on the Star Com Radio network.
Take Back America for the People is an educational nonprofit whose mission is to explain the true costs of corporate control of the US government.
It's been a year since the Abbott Government came to power. There have been broken promises since the first day and the Government is no closer to securing the support it needs to pass some of its most regressive budget and policy measures.
But the story after a year is how the Australian media has critiqued the last year.
Make sure you join the team as they vent their spleen about Abbott's first year in Government and the media.
It's always more fun with others.
Government and God's people have a very important relationship. As Christians we need to keep in mind that no matter where we live or what type of government we are under, we are first and foremost Christians. We can not rely on the human ideas and desires to perpel us into ungodly areas of our lives. We must remember Biblical examples such as Daniel, King David, Moses, and Paul, that went against the established rulers to stand firm in the word of God. Their acts did not come easy and they did not come without pain. But we must stand firm and stand for what is right. Our faith and the word tells us that God is in control. Are these just words or do we REALLY beleive it?
Thomas Abdul-Salaam , Imam Qasim Ahmed, American Government
1st HOUR: Thomas Abdul-Salaam on Quran and currrent events.
Imam Qasim Ahmed of the Islamic Learning Institute offers Rational Thinking on the Quran and Arabic words to help the listeners better understand this divine book.
American Coalition for Good Government Report talk about trends, politics, and current events. Q & A call 646.716.4478.
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