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

概要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Contents of a Complete Submission for the Evaluation of Proprietary Names" (proprietary names submission guidance). This guidance provides recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary names for drugs, including biological products, 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.