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Premier submitted comments in response to the Food and Drug Administration (FDA) draft guidance to help manufacturers put in place risk management plans (RMPs) to proactively mitigate drug shortages.
The draft guidance is designed to implement provisions that Premier advocated for in the CARES Act that require certain manufacturers to carry out measures that identify and evaluate risks to a drug’s supply, with a focus on quality issues. The draft guidance describes a framework for stakeholders to consider when developing RMPs that aligns with principles for high-quality manufacturing.
Premier’s comments on the draft guidance focus on three major areas: