Monthly Archives: October 2006

Send in the Clones

Posted on October 17, 2006 by Mark Senak

Today the Washington Post reports that the FDA is set to approve food and milk that comes from cloned animals.  Is it possible then, that we may hear an abundance of deja vu related remarks around mealtime in the coming … Continue reading →

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Transparency and FDA Advisory Committees

Posted on October 16, 2006 by Mark Senak

The agency is not doing everything that it should in order to support transparency in the advisory committee process, and it needs to do more. The relationship between members of FDA Advisory Committees and the industry that produces the products … Continue reading →

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Weekly Roundup – 10/13/06

Posted on October 13, 2006 by Mark Senak

The days are truly shorter now. For the superstitious amongst us, it is an auspicious day ending this relatively quiet week.  This morning it was so cold, one could see one’s breath upon exhaling, but the frost was not yet … Continue reading →

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Should the FDA Drop Food from its Mandate?

Posted on October 12, 2006 by Mark Senak

All of the food woes of the past few weeks raise some serious questions which have been before considered, but merit re-visitation.  First we had the spinach e-coli outbreak, the carrot juice botulism, the lettuce recall and a ground beef … Continue reading →

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Tracking Approvable Letters

Posted on October 11, 2006 by Mark Senak

There are three general outcomes from submitting a new drug to the FDA for approval.  First – approval, for which everyone hopes.  Second non-approval, which is the obvious bad scenario.  Third are approvable letters, issued by the FDA when they … Continue reading →

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