Weekly Roundup 8-12-11


A break in the weather with cooling temps and a Congress out of session made Washington a more bearable place this week.  Still, recovering from what has been the Bummer Summer may take a while and require some more salve.

In the meantime, it was a bit of a slow week – as August tends to provide.  The FDA did not issue a single press release, though perhaps today sometime.  Nevertheless, here is a little of what happened in our world this week:

  • FDA to Hold Public Meeting on IOM Device Approval Recommendations – Be careful what you ask for. At the request of FDA, IOM evaluated the 510(k) clearance process for devices and on July 29, the Institute issued a report that made eight recommendations for reforming the device approval process, which will now be the subject of an open public meeting to be held on September 3o, 2011.  Persons interested in attending the meeting must register and do so by September 15, 2011.  The link provided in the Federal Register notice that was provided for registration does not lead to registration information as of this writing but rather to a list of device-related meetings, on which this meeting is not listed that I could see.
  • Public Workshop on Mobile Medical Apps – Also in Today’s Federal Register, and also providing a link for registration that does not work, the FDA announced a meeting set for September 12 and 13 on the Mobile Medical Apps Draft Guidance announced earlier this month.  The meeting will also be available by Webcast and commentary is open until October 19.  Here is the page where you should be able to submit written comment, though no docket has been opened as of this writing.
  • PDUFA Date Set for BYDUREON – The three sponsors of diabetes 2 investigational compound Bydureon – Alkermes, Amylin and Lilly, took the step of announcing the PDUFA date for an FDA decision on the candidate is January 28, 2012.  BYDUREON is an extended release form of exenatide, long on the market, and according to the release, had its NDA submitted to FDA in May 2009 and received complete response letters from FDA in March and in October 2010 and has been approved in Europe since June 2011.

That’s it for me this week folks.  Have a good weekend and for those of you on vacation – enjoy!

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