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Vol. 12, Issue No. 4: 17 April 2013 - EXECUTIVE SUMMARY

PharmaguyWelcome to Volume 12, Issue No. 4 (17 April 2013) of Pharma Marketing News. See the featured article summaries below.

John Mack, Publisher & Editor
editor@news.pharma-mkting.com
@pharmaguy
Mobile Medical App Guidance & Beyond!
Keeping Up with Technology, Enforcement Headaches, and Still More FDA Guidance

DaVinci AndroidIn July, 2011, FDA's Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research, which is responsible for regulating medical devices, issued DRAFT guidance for mobile medical applications. The mobile industry as well as the medical device and drug industries have commented on the draft guidance and are anxiously awaiting the final guidance. The nearly 2-year delay may have been part of the reason for the recent House Subcommittee on Oversight and Investigations hearing regarding "Health Information Technologies: Administration Perspectives on Innovation and Regulation."

Many experts and industry representatives testified at these hearings, including Bradley Merrill Thompson, Member of the Firm at Epstein Becker & Green and General Counsel to the mHealth Regulatory Coalition. Thompson was also interviewed by Pharma Marketing News.

This article is a review of Thompson's testimony and interview. It covers the prospects for FDA's final guidance on regulation of MMAs and other regulatory issues that the mobile health community and FDA will likely face after publication of the "final" guidelines.

Topics include:
  • Draft MMA Guidance
  • FDA Addresses Fears of Over Regulation
  • The FDA Director Man Who Cried "Soon!"
  • Keeping Up with Technology
  • Taxing Innovation
  • Don't Pee on Your Smartphone - Keep FDA
  • Après La Guidance, Le Déluge
  • The Cheerios Lesson
  • Patient Groups Not Being Heard
  • Small Enterprises, Big Problems
  • Enforcement Issues
  • Other Mobile Guidance of Concern to Pharma
Download the full text PDF file here:
http://www.pharma-mkting.com/news/pmnews1204-article01.pdf

Get Social, #GetFit and Get Healthy
How GE Healthcare Uses Social Media & Gaming to Promote and Motivate Healthy Lifestyles

Get Social, #GetFit and Get HealthyA conversation with Ángel González, Founder & CEO, Ideagoras, and Verónica Botet, Global Manager, Digital and Social Media, GE Healthcare.

The discussion focuses on the #GetFit initiative, a worldwide competition and social media campaign designed to raise public awareness about cancer prevention.

Questions/Topics Discussed:
  • Why is GE Healthcare using gaming and social media for a cancer prevention awareness campaign? What is the goal? What are you measuring to determine if you have reached your goal? What products does GE Healthcare market that might benefit from a disease awareness campaign? Is there any evidence that SM and competition gets better results than more traditional campaigns?
  • What are some of the challenges to launching a global online campaign -- Languages, regulations? How do you deal with special challenges in some countries with tight control over social media such as China?
  • How has GE Healthcare prepared internally to manage social media campaigns? Does it have guidelines or a "playbook?"
  • Do you envision a day when GE Healthcare migt use social media and gaming to promote branded products?
Read more and listen to the podcast here:
http://www.news.pharma-mkting.com/pmn1204-article02.htm

Vol 12, #4 Contents




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