Monthly Archives: June 2006

Weekly Roundup – 6/23/06

I’m afraid the herd is quite thinned this week.  In my mind, the big news of the week was from the Hill – the Kennedy/Enzi legislation which I posted about yesterday.  There was not a lot going on at the … Continue reading

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Upcoming Legislation

More on legislation, this time more expansive… The New York Times carried a report yesterday of legislation to be introduced by Senators Kennedy (D-Mass) and Enzi (R-Wyo) that from all appearances is sweeping in the nature of the reforms it … Continue reading

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Proposed Legislation to Speed the Approval of Drugs

The current Congress has been a largely do-nothing body.  It has enacted less legislation than most.  They spent days last week debating gay marriage regarding an amendment everyone knew would fail while there were pressing matters demanding their attention.  They … Continue reading

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A New Day in Public Relations and Pharma Marketing

Related to yesterday’s posting, one of the consequences of the "new environment" of the post-COX-2s is that, because issues involving drug approval are getting more attention from both the public in general and policy makers in particular, the communications issues … Continue reading

Posted in Marketing | 1 Comment

What Does “Approvable” Mean?

There is a lot of word afoot that there are more approvable letters than there used to be.  An approvable letter is one of 3 outcomes from the FDA review process, other than approved and not approvable.  It can mean … Continue reading

Posted in FDA Policy | 7 Comments