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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.
DID YOU KNOW: The federal government mandates subcontracting or sharing the wealth so to speak, on large contract awards? Stay Tuned for the Top 3 Tips Small Businesses to use to Get Started
Contact me at Info@GCSToday.com
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.
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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.
Government is only as good as We the People. Government is required to protect the civil rights of all citizens. We the people vote for people we expect will help improve the quality of life for our communities, and for the nation. We are not monitoring the people we elect and the result is, government is only as good as we the people.
Politicians are governement workers who are elected into office to write bills and pass those bills into laws. Those laws areto be for the greater good of society as a whole. That said, different politicians must provide different resources and laws to their constitutents, based on geographical areaa. But those laws should never go against the greater good of society. Politicians are only as good as the people who votes for them.
The government workforce includes people who are hired to carry out laws, administer services, and support all communities. This workforce more times than not do a better job than the politicians. But again the government workforce is only as good as We the People in the community it serves.
To get better people as politicians, We the people must do our part.
To get better people administering services, supporting the communities, carrying out the laws, We the people must do our part.
Government is only as good as We the People
On the August 27, 2014 edition of "Nature Of Reality Radio" I welcome former Constitution Party Congressional Candidate, Government Insider, Christian, Patriotic American Business-owner, Environmentalist, and President of the Citizens Committee for a Restructured Government (CCRG) John Nicholson to discuss how our new world order puppets in government are screwing over the American people in a myriad of ways. John has been on a quest in life that led him to believe we are living in a tyrannical matrix, and now he desires to do something about it to bring more freedom to all.
John's site: http://www.ccrg.info
Are government grants really a waste of valuable, precious, time? The Grant Whisperer will give you five compelling reasons to apply for a government grant. Listen in for Grant Writing strategies to earn funds for your cause. Fundraising expert will share secrets to raising funds for your organization.
John Adams said, "Liberty cannot be preserved without general knowledge among the people."
Whether or not you are talking about the Federal, State or Local governments "freedom of information"or "transparency in government" is a vital ingrediant of public knowledge. All governmental bodies say they believe in the public's right to know; however, none of them are completely open with the information need by the public to decide for themselves what is going on within the walls of government.
Recent actions in the State of South Carolina demonstrate how things really work. Action within the CIA, FBI, the White House, Senate and Congress all point to the fact, Youwill know what they want you to know.
Join me this morning "In the Pickle Barrel"at 7AM-8:30AM EST as we discuss this very timely topic.
Welcome to the TechSource podcast series. This month we are highlighting the theme of cloud computing and government. As such, we are speaking with Mike Younkers, Director, U.S. Federal Systems Engineering at Cisco.
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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