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Home » PDUFA Section on Drug Shortages Will Overburden FDA, Former Official Says
PDUFA Section on Drug Shortages Will Overburden FDA, Former Official Says
June 27, 2012
The finalized FDA user fee bill requires early notification on manufacturing changes that could create drug shortages, but the language is so vague that drugmakers will flood the agency with reports, causing more harm than good, a former FDA associate commissioner says.