US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage

21 Sep 2023

Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.

Pharmaceutical manufacturers should check with the US Food and Drug Administration before shutting down operations in the wake of a bad FDA inspection, particularly if they are major suppliers of essential medicines, a frustrated Patrizia Cavazzoni, director of the agency’s Center for Evaluation and Research, told the Parenteral Drug Association/FDA Joint Regulatory Conference.

Cavazzoni's remarks pointed to the actions of Intas Pharmaceuticals Ltd. without naming the firm when she complained during an...