FDA Stresses Risk Management Plans

Patrizia Cavazzoni, MD, director of FDA’s Center for Drug Evaluation and Research (CDER), issued a statement on May 19, 2022 announcing a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, to help drug manufacturers develop, implement, and maintain risk management plans. The new guidance is part of the agency’s effort to address disruptions in manufacturing which cause drug shortages.

The draft guidance provides a framework for the development of risk management plans in alignment with the International Council for Harmonisation’s (ICH’s) Q9 Quality Risk Management guideline. Q9 identifies risk factors when developing risk management plans.

“Today’s draft guidance is an important step in what the nation needs to achieve an increasingly secure and resilient drug supply. For Americans to have access to an uninterrupted supply of safe, effective, and high-quality drugs, all entities involved in the manufacture of a drug should take every step available to reduce risks and threats to the drug supply chain. Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages,” said Cavazzoni in the statement.

Source: FDA