Weekly Roundup 8.7.14

August is supposed to be slow.  And lazy.  Laying around doing nothing.  That is what Marky the Cow is doing in this picture.  (For those of you who are new to Eye on FDA, Marky is a dairy cow in the state of Washington who was named for your’s truly.)  Marky the Guy though has not been laying around.  You may think I have disappeared, but I have just been very, very busy which means that there have been far fewer postings than usual. And in fact, last week there wasn’t even a Weekly Roundup.

But there is one this week and here it is:

  • FDA Publishes Fact Sheet on Ebola – Authorizes Test Use – The watchword of the week has been Ebola with the serious outbreak in Western Africa and the return home for treatment of two American medical personnel working there. This week, on August 5, FDA published “Fact Sheet for Patients:  Understanding Results from the Ebola Zaire (Target 1) Real-Time PCR (TaqMan) (EZ!rRT-PCR Test“.  The Fact Sheet is actually more of a Q&A and while interesting, it was also noteworthy that in answer to the first question – what is the Ebola Zaire Test – FDA stated that it the “test has not been cleared or approved by the U.S. Food and Drug Administration..” but “FDA has authorized the emergency use of this test under an Emergency Use Authorization (EUA)”.
  • CDC Puts Up Comprehensive Ebola Page – In addition, the Centers for Disease Control has put up a very comprehensive page on Ebola hemorrhagic fever on its web site covering topics such as transmission, diagnosis, signs and symptoms and treatment among other things.  The page appears to be updated daily with new information.  It includes fact sheets and chronologies and would appear to be an excellent resource for multiple stakeholders, including journalists.
  • FDA Modifies Hold on Investigative Ebola Treatment – A company that has been researching a possible treatment for Ebola announced this week that while a full clinical hold had been placed on the clinical trial of the investigative compound TKM-Ebola, FDA had conveyed to the them that the hold would be modified to a partial hold.  The Phase 1 clinical trial is looking at safety, tolerability and pharmacokinetics of administering the drug to healthy adult volunteers in single ascending doses and multiple ascending doses, though the company – Tekmira Pharmaceuticals – indicated in their release that the multi-ascending dose portion of the trial remains on hold.  The story was reported in media on August 7.

That’s it for me this week.  Have a good August weekend everyone.

Photo courtesy of Anne Becker.

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