In a bit of a change for today's post, I'm going to highlight some of the big news items that came through my inbox last week:

  • Check out Rebecca's post earlier in the week about the critical United States vs. Caronia case and its potential impact on off-label promotion. Even though the case was focused on a pharmaceutical sales representative, any precedent set by this ruling will likely carry over to devices, biologics, and combination products;
  • As many may know by now, the European Union has proposed changes to medical device regulations that will affect how companies operate within their regulatory infrastructure. The Regulatory Affairs Professional Society (RAPS) is hosting a webinar next week on the impacts.
  • A bill was introduced to, among other items, create a mobile health office at the FDA. Key notes to the bill are: HIPAA-focused support, a prize program (similar to the X Prize program I highlighted last week with Scanadu), and financial assistance.
  • FDA pledges to work with the Medical Device Innovation Consortium, a new industry group aiming to simplify medical device development.
  • FDA's latest pharma report shows that they approved the same number of drugs in 2012 as they did in 2011, marking the highest approval rating in 15 years! I, for one, would love to see the approvals weighted against the reported problems/recalls in that time to give a better statement of how effective FDA has been in these approvals.

Happy Monday!


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