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Ethics of Safety Studies for Marketed Drugs

Ethics of Safety Studies for Marketed Drugs Even the Average Joe couldn’t have missed the discussions regarding the safety risks of Avandia.  FDA is again in a tough spot and looking for answers.  Traditionally, Industry was not to make safety claims about drugs, just...

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PharmaVoice runs showcase feature focused on IRBs

In case you missed it in April, check out PharmaVoice's special coverage of commercial IRBs online here.   The article starts on page 50.  Our very own, Gretchen Bowker is quoted in the article! An intro to the Showcase on IRB article: "In accordance with federal...

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IRB Administrator as Chair

It comes back to matching skill sets for increased efficiency.  Odds are the Board chair was chosen, or elected, based on their leadership skills.  Or, was this person chosen based on their keen ability to organize documentation per standard procedures to ensure...

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