Monthly Archives: February 2008

Approvable Letter – Listing for 2007

I finally did it!  I have updated the listing of Approvable Letters that is housed in the left column of the blog under Resources by Me.  I now have all of the approvable letters listed that I have seen occur.  … Continue reading

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New Public Relations and Public Affairs Challenge for FDA

Last evening, CBS 60 Minutes ran an investigative report rather dramatically entitled "One Thousand Lives a Month" about the drug Trasylol, manufactured by Bayer for the control of bleeding in patients undergoing surgery.  The title of the piece is derived … Continue reading

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Fourth Quarter 2008 Warning Letters CDER

The pathetic rate of enforcement by CDER continues.  I am so stymied why some smart reporter hasn’t posed the question – what is happening when the amount of PDUFA dollars and money in the federal budget for FDA goes up, … Continue reading

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Weekly Roundup – 2/8/08

Inside the Beltway looking out, it was an exciting week.  Super Tuesday helped narrow the field a bit and candidate fundraising has been quite interesting.  Looking inside the Beltway, the Senate passed an economic stimulus package aimed at propping up … Continue reading

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The Juggernaut of Importation

Two divergent sets of events conspire this week to create circumstances that make the prospect of drug importation more likely. First, the one we all have heard about all week – Super  Tuesday.  The undeniable front runners are Clinton, McCain … Continue reading

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