Quick Guide To Recent FDA Draft Guidelines: "Risk Management Plans To Mitigate The Potential For Drug Shortages"

By Kate Smith, Director of Quality, PCI Pharma Services

Drug shortages can severely impact patients’ health, therefore global monitoring of drug product availability (human medicine and biologics) is an ongoing priority of Regulatory Agencies worldwide. This year the US Food and Drug Administration (FDA) drafted guidelines on best practice in aiding the prevention of shortages which may be caused by disruptions in the supply chain either by raw materials supply, manufacturing difficulties, or natural disasters such as hurricanes or the recent Covid-19 pandemic.

The FDA draft guidance outlines the need to "help stakeholders develop, maintain, and implement risk management plans (RMPs) to proactively assist in the prevention of human drug product and biological product shortages..." Learn more about these FDA draft guidelines in this quick reference guide developed by PCI’s Director of Quality, Kate Smith.