federal_register: 2012-30034

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2012-30034 Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication Errors; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Safety Considerations for Product Design to Minimize Medication Errors." The draft guidance provides sponsors of investigational new drug applications, new drug applications, biologics licensing applications, abbreviated new drug applications, and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) with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design. The draft guidance includes recommendations intended to improve the drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products. 2012-12-13 2012 12 https://www.federalregister.gov/documents/2012/12/13/2012-30034/draft-guidance-for-industry-on-safety-considerations-for-product-design-to-minimize-medication https://www.govinfo.gov/content/pkg/FR-2012-12-13/pdf/2012-30034.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Safety Considerations for Product Design to Minimize Medication Errors." The draft guidance provides sponsors of investigational new drug...

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