What Should You Do When Your CMO Gets Bad News from the FDA?
Thousands for prevention may be worth millions for a cure if a chain of 483s leads to warning letters and even shutdown of a vital product supplier.
By Wayne Koberstein, contributing editor S
ometimes the tip of the iceberg symbolizes the doomed ship itself — vast danger below, misjudged from above. A procession of seemingly small problems in the engine room belies overlooked structural faults that suddenly overwhelm the ship's integrity and send it to the bottom. Until the last moment, the captain on the bridge sails on at full steam, unaware of any danger large or small. Whose fault is it then? The engineer's for not informing the captain, or the captain's for not demanding to be informed?
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The CMO Leadership Awards 2012