FDA Controlled Correspondence Checklist

Summary

This checklist explains how to draft and submit a controlled correspondence to the U.S. Food and Drug Administration (FDA). Controlled correspondence is correspondence submitted to the FDA, by or on behalf of a generic drug manufacturer or related industry, requesting information on a specific element of generic drug product development. This checklist covers what must be included in a controlled correspondence, when to expect a response from the FDA, how to ensure a timely response, and what to do if the FDA's response contains ambiguities or requires further correspondence.