US FDA issues new guideline on emergency plans
This article was originally published in SRA
The US Food and Drug Administration has issued final guidance aimed at encouraging manufacturers of so-called "medically necessary drug products" and their raw materials and components to develop contingency production plans for use during emergencies that result in high absenteeism at production facilities.
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Focus on restarting production, easing drug shortages and completing quality assurance activities for quarantined batches, agency guidance says.
Guidance provides agency’s expectations for keeping virus out of drugs and facilities by protecting, monitoring, and excluding workers.