federal_register: 2016-08335

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2016-08335 Safety Considerations for Product Design To Minimize Medication Errors; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled "Safety Considerations for Product Design to Minimize Medication Errors." The guidance is intended for sponsors of investigational new drug applications (INDs); applicants of new drug applications (NDAs), biologics licensing applications (BLAs), and abbreviated new drug applications (ANDAs); and manufacturers of prescription drugs marketed without an approved application or over-the-counter (OTC) monograph drugs. This guidance provides sponsors, applicants, and manufacturers with a set of principles to consider while developing drug products using a systems approach to minimize medication errors relating to product design and container closure design. The recommendations in this guidance document are intended to provide best practices on how to improve the drug product and container closure design for all prescription and nonprescription drug products. This guidance also provides examples of product designs that resulted in postmarketing error. 2016-04-12 2016 4 https://www.federalregister.gov/documents/2016/04/12/2016-08335/safety-considerations-for-product-design-to-minimize-medication-errors-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2016-04-12/pdf/2016-08335.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled "Safety Considerations for Product Design to Minimize Medication Errors." The guidance is intended for sponsors of investigational...  

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