Monthly Archives: April 2007

Weekly Roundup 4-6-07

Posted on April 6, 2007 by Mark Senak

Yee Ha – it is the end of the week.  We are having unusual Spring weather here inside the Beltway.  The week started off with the fabled cherry blossoms peaking, casting their pink haze over the area, record pollen counts … Continue reading →

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Warning Letter Summary for 1st Quarter of 2007

Posted on April 5, 2007 by Mark Senak

As mentioned yesterday, there was a virtual drip of warning letters out of DDMAC during this past quarter, in line with the very low numbers of recent years.  There were also interesting comments entered by readers on that front in … Continue reading →

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DDMAC Enforcement Down – PDUFA Dollars Up – What is Wrong with that Formula?

Posted on April 4, 2007 by Mark Senak

As we are in the midst of approval for PDUFA IV, there has been a lot of talk from the FDA about the need for increased funds to bring greater focus on drug safety and even monitoring of marketing activities. … Continue reading →

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Ketek, Testimony and a Growing Mess

Posted on April 3, 2007 by Mark Senak

Remember the Cat in the Hat?  The book, not the movie.  It is a story about some children who make a small mess of things.  The cat in the hat comes along, and through some inept clean up, the mess … Continue reading →

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A Conversation with the FDA Associate Commissioner for Public Affairs

Posted on April 2, 2007 by Mark Senak

Today begins a new era here at Eye on FDA as I am placing on-board my first podcast.   This is the beginning of a series of podcasts I am planning that will appear from time-to-time.  On Friday, I had the … Continue reading →

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