FDA Guidance: Is anyone monitoring this?

In the 21st Century FDA has issued a lot of guidance documents, but few updated regulations. Por Quoi? In this 2008 article published in RAPS Regulatory Focus I discuss some important guidance documents to assist sponsors of clinical research “Monitor the progress of the investigations.” The article has taken on a new urgency since FDA seems to be intent on increasing enforcement on clinical trial sponsors. At least this is indicated from Warning Letters issued in the past year or two.


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