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Ken Leiper

Which Directives Should FDA Scrap, Under Obama's Order?


In January, President Obama issued an executive order demanding that government agencies, including FDA, submit a plan for reviewing existing regulations. Their aim, he said, should be to examine rules that could be outmoded, ineffective, insufficient or excessively burdensome, and to "modify, streamline, expand or repeal" them based on accumulated knowledge.

From 'On Pharma'

EZ Pass Testing, Coercion and Buck Passing: A Tale of Broken Pharma QA and QC. Sound Familiar?


Just read Mina Kimes' enlightening account of the J&J McNeil quality disaster in Fortune. Forget about the fact that the adulterated products did not and most likely would not have harmed consumers, the problems cited are very serious and go straight to the heart of GMP's.

From 'On Pharma'