Monthly Archives: March 2007

Weekly Roundup – 03/30/07

Posted on March 30, 2007 by Mark Senak

This Weekly Roundup did not come soon enough for me!   And yet it is hard to believe that the first quarter of 2007 is over.  Next week, I’ll do the look back at the Warning Letters for the quarter.  But … Continue reading →

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Advice Column: Effectively Communicating Achievement

Posted on March 28, 2007 by Mark Senak

As per the posting earlier this week about the EMEA, and in preparation for an upcoming trip to the U.K., I’ve been reading and comparing the Web sites of the FDA with the EMEA.  It provides some interesting points that … Continue reading →

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PDUFA IV Recommendations from FDA

Posted on March 27, 2007 by Mark Senak

The FDA is between a rock and a hard place when it comes to PDUFA.  The Prescription Drug User Fee Act provides a great deal of funding by which the agency can afford to engage in a wide range of … Continue reading →

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The $50,000 Mystery Question

Posted on March 26, 2007 by Mark Senak

A lot of the commentary about the recently proposed changes to the FDA’s Advisory Committee rules for participation centered on the mysterious limit of $50,000 applied to the interests of members in industry.   Where did that figure, many have asked, … Continue reading →

Posted in Current Affairs, FDA Image, FDA Policy | 1 Comment

Weekly Roundup – 3-23-07

Posted on March 23, 2007 by Mark Senak

It is that singular time of year when, in the morning while walking the dogs, the air is heavily scented with burning fireplaces as neighbors gather around the fireplace on a chilly morning to have their oatmeal, coffee and read … Continue reading →

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