federal_register: 2020-27057
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-27057 | Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products." FDA is issuing this draft guidance to help sponsors develop human nonprescription drug product proprietary names. This draft guidance describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal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. The draft guidance also describes the framework FDA uses in evaluating proposed proprietary names for nonprescription drug products, which is available to sponsors to use before marketing a nonprescription drug product bearing a particular proprietary name. This draft guidance is issued in response to industry stakeholders' requests to specifically address the approaches for naming of human nonprescription drug products. | 2020-12-09 | 2020 | 12 | https://www.federalregister.gov/documents/2020/12/09/2020-27057/best-practices-in-developing-proprietary-names-for-human-nonprescription-drug-products-draft | https://www.govinfo.gov/content/pkg/FR-2020-12-09/pdf/2020-27057.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products." FDA is issuing this draft guidance to... |