Daily Archives: August 11, 2008

Cardiome and Astellas Announce Receipt of FDA Approvable Letter for KYNAPID

Today is supposed to mark the day that the FDA quits submitting approvable letters and starts issuing "complete response letters" – but it looks like one flew off the shelf just in the nick of time – at least per … Continue reading

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Warning Letter Summary – Second Quarter 2008

Warning letters from the FDA’s DDMAC have only been at the pace of a trickle under the Bush Administration, and the second quarter was no exception, though there was at least one interesting lesson to be learned. In April, DDMAC … Continue reading

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