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Regulatory Update

Posted 01 March 2010

The US Food and Drug Administration (FDA) announced the availability of Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names. This document will assist manufacturers in completing the submission, which is required for the review clock to begin. It will also help the agency evaluate the safety of proposed proprietary drug and biological product names by taking into account factors that can contribute to medication errors. In this guidance FDA discusses the information it requires from the manufacturers for the assessment of:


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