Weekly Roundup 7-29-11

Goodness.  The year is over half over and we are about to slip into a steamy August.  The weather here in Washington, D.C. relented this week, with lower humidity and pleasant temperatures, but the frosted glass this morning indicates a return to the normal summer humidity and heat combo.  Even the summer wild flowers look a little tired.  My lawn is a squalid, barren lot…..

And if you are like me, you decided to stop watching the news this week.  Seriously, try it – I feel much better for it.  But here is a little bit of the news I did watch out for this week:

  • CDER Unveils Strategic Science and Research Agenda – This week CDER announced its research agenda via publication in the Federal Register and noted that they are opening up a 60-day comment period.  Oddly, the press release issued by the agency about the agenda does not provide a link where you can offer comment.  The agenda outlines 7 areas of concentration that ranges from improving access to postmarket data to enhancing the individualization of patient treatment.
  • FDA Issues Draft Guidance on Device Changes that Warrant New Premarket Review – Much attention has been focused of late on the approval process for new devices coming to market, but this week the FDA focused instead on what happens when existing devices are upgraded or changed.  When does “new and improved” mean that it is new enough that it warrants a new approval process?  The agency issued a draft guidance seeking to answer that question.  In the agency’s announcement on the subject they stated that the draft “clarifies the kinds of changes that trigger the need for a new submission, such as specific kinds of labeling changes, changes to the technology used in the device, changes in performance specifications, manufacturing changes, and changes in the materials used in the manufacture of the device.”  The agency noted that this is one of 25 action items related to FDA’s Plan of Action for 510(k)s.
  • GAO Issues Report on Social Media and Federal Agencies – Nearly every cabinet level office has a YouTube channel, a blog, a Facebook page and a Twitter feed (I checked!).  Even agencies such as FDA, have them all, as does CDC and NIH.  But hacking and breaches are widespread and notable.  This week the GAO issued a report recommending that federal agencies undertake privacy assessments and security risk assessments of their social media practices.  They do this in the way that only government can – through a repetitious and uneconomic use of language – but they raise a good point whether you are a government agency or not.  Bottom line, if you are engaged in social media as an entity, you should undertake a comprehensive privacy and security assessment of your practices, identify holes and plug them.  That is everything from protecting the populations you serve (especially if you are a medical provider) to how you develop your passwords to whom you allow to speak on behalf of yourself.  (One pharma company recently suffered a hack attack.)  While you are at it, do a content review as well.  Make sure you are not just talking at people with what you want to say, rather than speaking with people about things they want and need to hear.

That is all.  I’m continuing my news boycott for another week.  In the meantime, have a wonderful weekend and stay cool!

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