Draft Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names; Availability

Resumen

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Contents of a Complete Submission for the Evaluation of Proprietary Names." This draft guidance provides recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary drug and biological product names and other factors that, in association with the name, can contribute to medication errors. In addition, FDA intends to use this information in the assessment of promotional aspects of proposed proprietary names.