Preparation of "Feedback Letter"

After the Division of OTC Drug Products completes its review, a feedback letter explaining CDER's actions or recommendations may be prepared. This letter would be forwarded to the submitter. A copy would also remain on file at the Dockets Management Branch. 

In some cases, the agency responds to a submission by addressing the submitted issues in a rulemaking (i.e., monograph or amendment), and a feedback letter is not sent to the submitter.