Category Archives: Approvable Letters

Impact of Approvable Letters 2007 – Part 1

I do not currently have a way of counting and comparing the number of approvable letters issued over the past few years, but my gut tells me that 2007 was a banner year.  I am currently compiling the 2007 list … Continue reading

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Approvable Letter Mania

I am beginning to believe that there have been a flood of approvable letters, though I haven’t gone back over the years to count the rate – but my gut tells me that the rate has increased.  It is a … Continue reading

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Neurochem Gets Approvable Letter

The FDA has issued another approvable letter – this time to Neurochem for eprodisate (KIACTA(TM)) for the treatment of Amyloid A (AA) amyloidosis.  This was not good news on two fronts – first, it was the product’s second approvable letter … Continue reading

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What’s at Stake with Formal Dispute Resolution

Recently, two pharmaceutical companies announced that they would be seeking Formal Dispute Resolution (FDR) because of FDA decisions regarding their products.  Genta announced in April that the company would be filing one over a non-approvable letter for their investigative product … Continue reading

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Two More Approvable Letters Issued

Wow – the approvable letters are flying off the shelves.  If you are not familiar with approvable letters, see my posting "What Does Approvable Mean?"  Or you may wish to listen to my podcast on the subject of approvable letters.  … Continue reading

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