FDA's Beleaguered Criminal Investigations Unit Now Facing Congressional Scrutiny
After staff complain about becoming the 'Botox police,' a House committee is asking FDA for an update on two previous reports raising issues of management and morale in the Office of Criminal Investigations.
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George Karavetsos’ last day is Jan. 20, which coincidentally is the start of the Trump Administration. Office of Criminal Investigations has been subject of recent Congressional scrutiny.
Republican senators argue reports show that FDA needs significant reform; discussion of Cures and User Fee legislation will now likely focus on what the plan should be.
Time is of the essence in complying with the serialization provisions of the Drug Supply Chain Security Act, warns Pfizer official. Too many manufacturers are waiting on the sidelines instead of getting these systems up and running before new serialization mandates go into effect in 2017.