Category Archives: Complete Response Letters

Gilead Demonstrates the Folly of Formal Dispute Resolution

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

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Complete Response Letter Review for December 2008

"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

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Speaking of Complete Response Letters

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

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FDA Requests Cephalon to Enhance Risk Mitigation Strategies Consistent with Company’s Recommendations

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

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Gilead Receives Complete Response Letter from FDA for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis

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

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