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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!!!!!!!
Welcome to the SC&H Group podcast series. Today, we are speaking with Angelo Poletis, Principal with SC&H Group and Chris Davidson, Senior Manager with SC&H Group, about key tax planning strategies for government contractors
Muslimah Education, 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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Pastor Demetrios, Host Of Wall Less Ministries (Ray Of Hope), Discusses the simple introduction of "God's How to Recieve The Gift of Salvation and Connect with God in fellowship through Jesus, The Christ - The Word -The Son Of God - God"
8 But what saith it? The word is nigh thee, even in thy mouth, and in thy heart: that is, the word of faith, which we preach;
9 That if thou shalt confess with thy mouth the Lord Jesus, and shalt believe in thine heart that God hath raised him from the dead, thou shalt be saved.
10 For with the heart man believeth unto righteousness; and with the mouth confession is made unto salvation. Romans 10:8-10 KJV
1 That which was from the beginning, which we have heard, which we have seen with our eyes, which we have looked upon, and our hands have handled, of the Word of life;
2 (For the life was manifested, and we have seen it, and bear witness, and shew unto you that eternal life, which was with the Father, and was manifested unto us;)
3 That which we have seen and heard declare we unto you, that ye also may have fellowship with us: and truly our fellowship is with the Father, and with his Son Jesus Christ. 1 John 1:1-3KJV
Reiceve By Grace through the Redemption that is in Christ Jesus.
In this episode we discuss how we all could work less and be more productive under a technologically driven socialist economy and society. Today there are over 7 billion people on the planet, but yet the majority of us work just as hard and as long as we were working a hundred years ago. While technology has automated many of the jobs and tasks people used to perform, technlogical unemployement under capitalism has lead to more unemployment, lower pay, and more work hours—that is, except for the rich elite. So listen in, and let's talk about work and leisure under socialism.
rtconnects radio would like to thank all the callers, listeners, and talent that is submited in the showcase.
Tune-in today at 1pm est. to hear helpful hints from the marketing guru Charlie Blue on how to get government grants to fund your business career.
Catch THE GREAT DJ ASIV'S musical selection.
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For as long as I can remember there has been this ongoing battle of who is responsible for our children's well-being, day-to-day care, what foods they should eat, education, vaccinations, whether they should where seatbelts/car seats and any other issue surounding our children.
Most parents say something like, "My children are my responsibility."
Some parent couldn't care less. They would just as soon let other people or the government take the responsibility of their childrens care and up bringing.
Dr. David Meola, Constitutional Expert and educator, will be my guest for the morning as we discuss this critical issue.
If you are a parent, grandparent, soon-to-be parent or any other concerned person please join Dr. Meola and I as we dig into this issue.
Showtime:Tuesday, September 16, 2014, 8:00AM-10:00AM EST.
You are welcome to join in the conversation either in the chat room or you can join the discussion live on air by calling (toll free) 1-855-236-2486.
We would love to hear from you and any issues you have with this topic.
in Pop Culture
45 Day's.That is how many day's left before Halloween! So, you better be getting your stuff together for the big show.Harry and Derek are getting excited about the up and coming day.We will be talking about other thing's too,so you have to lisen in so as not to miss some good stuff.Stay Nerdy!
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:…”
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