Monthly Archives: January 2007

Does FDA Labeling Matter Where States Are Concerned?

Posted on January 23, 2007 by Mark Senak

Recently, the FDA indicated that it would be alright with cloned food, even if it were not so labeled.  This was a big mistake. Though many experts have said that it is unlikely that any cloned food would actually end … Continue reading →

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Weekly Roundup – 1/19/07

Posted on January 19, 2007 by Mark Senak

Though much of the nation has been in a deep freeze, it has been quite balmy here.  Though it is finally cold here in the nation’s first city as we are assessing the whirlwind of activity contained in the famous … Continue reading →

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Warning Letter Volume on the Decline

Posted on January 17, 2007 by Mark Senak

The very day after posting about the upcoming FDA meeting on PDUFA IV, I was getting ready to check out the Warning Letters for the 4th Quarter when I decided to look back on the DDMAC issued letters going back … Continue reading →

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PDUFA IV Meeting Announcement

Posted on January 16, 2007 by Mark Senak

In today’s Federal Register, there is a whopping entry published from FDA regarding that publishes proposed recommendations for PDUFA IV that will cover years 2008-2012.  Whopping refers to its length- 11 pages in PDF!  It makes good reading if you … Continue reading →

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Weekly Roundup – 01/12/07

Posted on January 12, 2007 by Mark Senak

My apologies for the lack of postings this week.  The new year has gotten off to a quite busy start and I was on the road, but unable to access Typepad so that I could post.  I hope to make … Continue reading →

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