February 19, 2009
The FDA has a policy and a guidance for companies that want to pursue Formal Dispute Resolution (FDR) . This lays out the procedure by which companies can appeal an FDA decision about a product. It has been demonstrated many … Continue reading →
January 8, 2009
"Complete Response Letter" is a kind of funny term. It implies finality when in fact, the outcome means that there is more to do. During December, a number of companies got their marching orders from the FDA. Here is a … Continue reading →
December 16, 2008
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 … Continue reading →
September 24, 2008
This is not exactly under the headline of news – a Complete Response Letter (CRL) was issued to Cephalon on the 15th of September for its supplemental New Drug Application (sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] as a treatment … Continue reading →
September 22, 2008
Since Complete Response Letters (CRLs) have become the fashion for CDER after August 11, I have tried to make it a point to see how different companies respond to the receipt of such a letter in public communications. As I … Continue reading →