Generic drugs scandal

The FDA had thus firmly established its jurisdiction over clinical trial materials through the cGMPs preamble and the IND guidelines prior to the 1989 generic drug scandal. 

The scale of the response to this issue provides a case history that highlights another skill and training required within pharmaceutical medicine, namely crisis management. This is a very important technique which is critical in addressing substantive health issues. In a relatively recent history of healthcare, there have been several such issues, for example Zomax, Oraflex, Tylenol tampering, toxic shock syndrome, Reye s syndrome, the Dalcon shield, contaminated blood supply, silicon implants and the so-called generic drug scandal , to mention but a few. 

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