Weekly Roundup 9.26.14

I bring you the Weekly Roundup today from Cape Cod where there is a lovely sense of autumn in the air, but blue skies and lovely shoreline allowing us to still remember the summer’s most pleasant days.

And here is what happened this week in reality-based Washington, D.C.

  • Ebola Candidate Treatment Emergency Use Reuters reported this week that FDA was allowing the emergency use of Tekmira’s investigative compound TKM-Ebola being studied as a treatment for Ebola. Canada also issued a similar authorization.  And the company announced this week that it would be joining an international consortium to conduct clinical trials for new treatments in West Africa.
  • FDA Warns Purveyors of Ebola Treatments – On a related but entirely different note, FDA issued warning letters to 3 companies that the agency said were marketing preventions and/or cures for Ebola.  The letters were issued on September 22 and 23 and represented a range of types of products.  FDA has put up a web page on Ebola and overviews distinctions between investigative compounds and fraudulent products.
  • CyberSecurity and Medical DevicesFDA announced a public workshop for October 21 and 22 to be held in Arlington, Virginia entitled “Collaborative Approaches for Medical Device and Healthcare Cybersecurity” and the purpose of the meeting is to identify barriers to promoting cooperation and to consider strategies to overcome various challenges.
  • Social Media Guidance Comment Period Extended FDA announced that it would be extending the time period for comment from the public regarding the two social media guidances issued in June.  The agency took five years to produce the guidances and is seeing fit to give the public a bit more time to provide input. According to the notice sent by FDA, the time period will be extended from September 29 to October 29.

That’s it for me.  Back to vacation.  Have a good weekend everyone.

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