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

  2. 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 …

  3. 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. …

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

  5. 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 …

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

  7. 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 …