Weekly Roundup – 4/29/06

J0289047 As part of a new feature, I’ve designated Friday’s as mop-up time – a review of what happened during the week with handy links to the sources.

  • GAO Issues Review of FDA on Safety – Unless you had been living under a rock, you would have taken note that the week began with a critical review of the FDA and its ability to consistently and effectively respond to emerging safety issues when the General Accounting Office report issued on Monday, April 24.  Essentially the GAO states that the FDA could be more vigilent on matters of post-marketing safety and should be supplied with the necessary tools to get the job done.  It is, I suppose, a matter of future debate as to how that would be paid for. 
  • Changes Made to this Blog – I added two resources to the right that offer a glossary of terms in connection with clinical trials.  They are really good and you can find them under the heading Good Learning Tools.   
  • Generic Pravachol – As statins neared the end of their patent life, there were two failed attempts to get them to move from RX to OTC.  Now the first generic has been approved by the FDA. 
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