Naming a New, Untitled Document: Click UNTITLED DOCUMENT title in top left corner to rename your file. Name your document and Click OK.

All correspondence should include a subject line that clearly identifies the submission as a Response to Untitled Letter. You are encouraged, but not required, to submit your response in eCTD...

mputer, you can download it. In your document, go to the File menu and point your mou. e to the Download as option. Select one of the following file types: HTML (zipped), RTF, Word, Open. Office, …

c To download your document as a Microsoft Word document or as a PDF, click the ‘File’ menu and hover .

All correspondence should include a subject line that clearly identifies the submission as a Response to Untitled Letter. You are encouraged, but not required, to submit your response in eCTD...

Untitled Letters and Warning Letters Officia l communication from FDA issued to registrants and labelers

Definitions Untitled Letters Initial correspondence with regulated industry that cites violations that do not meet threshold for a Warning Letter – For circumstances where FDA needs to communicate with …