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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.
Each week Candace Benson of CampTech Online and Deborah Chaddock Brown of AllWrite Ink talk about the pros and cons of social media, technology and ways businesses can connect with their customers.
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 is the first podcast to come from Voluntary Media Networks (VMN) where I, Alex, talk about the Ferguson, Missouri incident and riots, about the ideas statists generally have when talking about the use of force, and about the general biases most protestors and viewers of the media have when it comes to issues such as the Ferguson incident.
GatorNation! After a disapointing finish to last season, The University of Florida finished the year at a disapointing 4-8 after a 4-1 start. Can they rebound this year and stop the current losing streak? Can the return of Jeff Driskel at Quarterback and a good young crop of receivers push the limits of the offense to levels last seen years ago? Who are the players to watch and what amazing talent is waiting to break out? Joe Pim and Jeremy York answer all this and more on this week's EndZone: The SEC Florida Gator Preview (Presented by Impact Media)!
Join us for another Indie Cafe hosted by Spencer Drate / Judith Salvatz and Holly Stephey of Red Velvet Media . Spencer Drate and Judith Salavetz are award-winning designers of album art for countless industry legends
Jesse Malin was born in Queens, New York. Jesse Malin’s passion for music began at an early age. Upon receiving his first nylon stringed acoustic guitar, Jesse taped an old 1950’s reel-to-reel recorder with a beat-up attached microphone to its body and the soon-to-be songwriter began his musical career.
Malin began playing live the age of twelve years old in the seminal hardcore band Heart Attack. After the group’s disbandment in 1984, Jesse and his childhood pals formed the rock and roll band D Generation and released three albums, touring the globe several times over before parting ways in 1999. Following several in-between bridge bands, including PCP Highway and Bellvue, Jesse Malin embarked on a solo career and has released five acclaimed records. Over the years Malin has also worked in both film and radio, currently co-hosting a monthly radio show on Sirius XM alongside John Varvatos, and is now completing production on a new album set to be released in 2015.
I" Take a Medium, Please… Did you think I meant French fries or a diet coke? Or did you think I just fell into the Gap to buy a new t-shirt?
Media plural of Medium is all around you! Young Media Critics continue to discuss, analyze, evaluate, examine and comment on the various forms of media and the messages communicated to us every day.
Join Young Media Critics on Blogtalkradio.com, Tuesday, August 12, 2014 at 5:00 p.m (EST) as they introduce the Media Literacy Five Core Concepts. Today's episode combines last week's Media Literacy Five Key Questions to "pull back the curtain" on media messages!
Your host Jeremy York along with new Impact Media college contributor Joe Pimm give their take on the recent college SEC news plus, a preview of the current champions of the SEC: The Auburn Tigers! Can the champs retain the trophy this year? Or did they lose too much in the off-season? All this and more on the new Impact Media show EndZone: The SEC!
William “Bill” Bean is an internationally known author, lecturer and media personality with over 30 years of experience in the paranormal field. He has written two books about his experiences, the first entitled Dark Force (2006), which inspired the Discovery
Channel docu-drama “House of the Dead,” and the second entitled Delivered (2010). Bill’s story has given rise to over 1000
Bill has been featured as a paranormal expert on over 30 television shows on the Discovery, Syfy, and Travel Channel as well as news programs on the Fox, CBS, and ABC networks. He has also been featured in over 30 periodicals and news publications,
including the Rolling Stone Magazine (“Encounters of the Strange
and Unexplained”), as well as several published books.
Your host Jeremy York is joined by college expert Joe Pim to preview the LSU Tigers upcoming season! Can Les Miles continue to put up great records as the captain of the ship? Will 10+ wins get them higher than 3rd in the division? Can they reload after losing some of the most talented players in school history to the NFL? They guys answer all the questions plus offer their preidictions for the Tigers!
The Young Media Critics…voices of the future made a few changes in the program. They will kick off the 2014-2015 season talking about media, literacy, digital messages and more with the Young Media Co-hosts.
Our show is based on “The Inquiry Process/ Free your Mind/Express Your View”-components of media literacy and media education as defined by The Center on Media Literacy (www.medialit.org ). It is not a show to bash the media.
The Young Media Critics Co -Host will share with the listeners how their lives are influenced by the media messages that surround them every day.
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