FDA Releases Draft Guidance for Medication Product Design

December 19, 2012 | Strategic Insights for Health System


The U.S. Food and Drug Administration (FDA) has announced the availability of Safety Considerations for Product Design to Minimize Medication Errors, a draft guidance document designed for sponsors of investigational new drug applications, new drug applications, biologics licensing applications, abbreviated new drug applications, and nonprescription drugs marketed without an approved application (e.g., monograph). The draft guidance provides a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design.

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