Monthly Archives: June 2006

Flooding

Posted on June 30, 2006 by Mark Senak

Sorry everyone, am dealing with the rains here in DC.  Will be in full force next week!

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Everyone Piles Up on FDA for the Election Cycle

Posted on June 29, 2006 by Mark Senak

I’ve been on the road traveling for several days and lots has been happening.  The occasion of the 100th anniversary of the FDA’s existence has sparked a great deal of commentary.  Gang up!  Remarkably, all on the same day, Public … Continue reading →

Posted in Crisis Communications, Current Affairs, FDA Image | Comments Off on Everyone Piles Up on FDA for the Election Cycle

The Supremes and Generics

Posted on June 28, 2006 by Mark Senak

You have to admire Washington.  It is the only city in the United States where, when you don’t do anything, you make news.  At least if your name is Supreme Court. Monday the Associated Press noted that the Supremes have … Continue reading →

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A Rule of Thumb – Some Tips for Pre-Approval Communications Around Data Milestones

Posted on June 27, 2006 by Mark Senak

When an investigational product is working its way down the clinical trial path, it is natural for a drug sponsor to want to communicate about its progress.  But when it comes to pre-approval communications, there are some caveats, particularly respecting … Continue reading →

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Generics and Pricing, Part II – A Drug, A Price and a Senator

Posted on June 26, 2006 by Mark Senak

Recently Merck announced a lowering of the price of Zocor (simvastatin) in a move that presumably will put their brand name drug in a competitive position vis a vis an upcoming generic product, just approved by the FDA.  This brought … Continue reading →

Posted in Marketing, Pricing and Value | 1 Comment