Monthly Archives: June 2009

Weekly Roundup 6/05/09

Posted on June 5, 2009 by Mark Senak

I am really sick of rain.  Really.  This morning there was a duck floating in my back yard.   A duck.  Here is what happened this week that was interesting to me and I hope will be to you too. FDA … Continue reading →

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The Inevitability of User Fees for Food Safety

Posted on June 4, 2009 by Mark Senak

For a long time now, I've been convinced that there would emerge something on the order of a FPUFA (Food Producer User Fee Act) not only because it is fun to say, but because for a long time, there has … Continue reading →

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Winds of Change at FDA

Posted on June 3, 2009 by Mark Senak

Yesterday the Obama Administration announced a new Task Force at FDA to delve into the issue of transparency.  Later that same day, the FDA opened up a new part of its Web site devoted to FDA transparency and launched a … Continue reading →

Posted in FDA Image, FDA Policy | 1 Comment

Sunshine on FDA Decisions

Posted on June 2, 2009 by Mark Senak

The New York Times reports that the Obama Administration will announce today that a panel will be formed to make recommendations on how information about FDA decisions can be made more transparent related to approvals for drugs and devices.  That effort … Continue reading →

Posted in FDA Policy | 1 Comment

Warning Letter Quarterly Update, Last Quarter 2008, First Quarter 2009, Part 3

Posted on June 1, 2009 by Mark Senak

Last week I posted Part 2 of the examination of the past two quarters for FDA DDMAC letters.  The week before that, I posted Part 1.  Finally, I am done with Part 3, examining the last quarter of 2008 and … Continue reading →

Posted in Warning Letters | 1 Comment