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.
FDA Guidance: Is anyone monitoring this?