federal_register: 2020-27058

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2020-27058 Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Best Practices in Developing Proprietary Names for Human Prescription Drug Products." This document provides guidance to sponsors on the development and selection of proposed proprietary names. This guidance describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations and provides a voluntary framework for evaluating proposed proprietary names before submitting them for FDA review. This guidance finalizes the draft guidance issued in May 2014 entitled "Best Practices in Developing Proprietary Names for the Drugs." 2020-12-09 2020 12 https://www.federalregister.gov/documents/2020/12/09/2020-27058/best-practices-in-developing-proprietary-names-for-human-prescription-drug-products-guidance-for https://www.govinfo.gov/content/pkg/FR-2020-12-09/pdf/2020-27058.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Best Practices in Developing Proprietary Names for Human Prescription Drug Products." This document provides guidance to sponsors...

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