Monthly Archives: July 2009

When Transparency is Easy – Advisory Committee Transparency

There has been a good deal of talk coming out of the FDA these days about improving transparency.  For example, there has been set up a Transparency Task Force, and on June 24, the FDA held a Transparency Meeting which … Continue reading

Posted in FDA Policy | 2 Comments

FDA Lags in the Digital Space Compared to Sister Agencies

As if it were needed, yesterday one more example emerged yesterday to demonstrate how the FDA is failing in the all important digital space.  The National Institutes of Health announced a collaboration with the Wikimedia Foundation that has the aim … Continue reading

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Does the FDA Have More to Talk About?

There are a number of angles that one can look at the FDA to see if there are indeed winds of change blowing through the agency.  Recently, we looked at the level of warning and untitled letters coming out of … Continue reading

Posted in FDA Policy | 1 Comment

How Many Czars Does it Take? DeJaVu on Food Safety at the FDA

In May 2007, the FDA responded to an increasingly vocal set of critics in Congress by appointing Dr. David Acheson at FDA to "Assistant Commissioner for Food Safety" – with the media quickly dubbing him as the new "food safety … Continue reading

Posted in Food | 1 Comment

Warning Letter Summary thru Second Quarter 2009, Part 2

Yesterday we examined the quantitative aspect of the warning and untitled letters from FDA's DDMAC – today we are going to look at the substance of the letters to discern any lessons learned.   And just for the record, the … Continue reading

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