FDA preps for drug shortages via manufacturing disruption guidance

In anticipation of disruptions to drug supply chains and spikes in demand driven by the COVID-19 crisis, FDA issued guidance to industry on how to communicate manufacturing changes so that the agency can help prevent or mitigate shortages.

The guidance document, published Tuesday, instructs manufacturers to notify FDA of permanent discontinuances or interruptions as soon as possible, and no later than five business days after the issue occurs, if it is not possible to give the six months of advance notice the agency typically expects. ...