Here I am – speaking of Complete Response Letters. What follows is a short tutorial on the communications aspects of CRLs.
NOTE ADDED OCTOBER 19, 2010 - There has lately been a great deal of interest in this video from investors of a company with a drug candidate that has received a CRL from the FDA. A note of clarification about the video. It was created for communications professionals to help understand the communications ramifications of the change from the old way the FDA responded to NDAs – with an approval, an approvable or no approval, to the way it is today – an approval letter or a complete response letter. A CRL lays out a pathway for approval by stating the requisites the FDA wants to see fulfilled before it might grant approval. Whether or not a company does, or even can meet those requisites, is another matter. The company may find that the pathway laid out is not possible or desirable.