The U.S. House of Representatives yesterday passed the Prescription Drug User Fee Act reauthorization, a legislative package that includes an FDA provision to prevent and mitigate national drug shortages.
Title IX of the reauthorization would require drug manufacturers to notify the FDA in advance of an anticipated disruption in the production of key drugs, enabling the agency respond in a timely fashion. Title IX would also authorize the Secretary of the Department of Health and Human Services to process expedited inspections of drug applications and manufacturing facilities in an effort to help alleviate pending drug shortages.
The House version of the PDUFA will now be reconciled with the Senate, which approved the Act on Monday.
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Title IX of the reauthorization would require drug manufacturers to notify the FDA in advance of an anticipated disruption in the production of key drugs, enabling the agency respond in a timely fashion. Title IX would also authorize the Secretary of the Department of Health and Human Services to process expedited inspections of drug applications and manufacturing facilities in an effort to help alleviate pending drug shortages.
The House version of the PDUFA will now be reconciled with the Senate, which approved the Act on Monday.
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