federal_register: 2014-12348

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2014-12348 Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Best Practices in Developing Proprietary Names for Drugs." The draft guidance focuses on the safety aspects in the development and selection of proposed proprietary names for all prescription and nonprescription human drug products and biological products. The draft guidance describes naming design practices to help avoid medication errors and provides a qualitative systematic framework for evaluating proprietary names before submitting them for FDA review. FDA is issuing this draft guidance to help drug and biologic product sponsors develop proprietary names that do not cause or contribute to medication errors or otherwise contribute to the misbranding of the drug. 2014-05-29 2014 5 https://www.federalregister.gov/documents/2014/05/29/2014-12348/draft-guidance-for-industry-on-best-practices-in-developing-proprietary-names-for-drugs-availability https://www.govinfo.gov/content/pkg/FR-2014-05-29/pdf/2014-12348.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Best Practices in Developing Proprietary Names for Drugs." The draft guidance focuses on the safety aspects in the development and...

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