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The purpose of a "no" response letter is to leave the reader with - a. reasons for the rejection of the request.
Reply letters are letters that provide the information asked for or give the answer to certain questions. Whether the reply letters grant or deny the information or favor requested, the characteristics of reply letters need to be observed.
A response letter is an answer to an original letter asking a question or looking for information. These are especially common business communications. To craft a perfect response letter, first review the original letter carefully and determine what the writer was asking you.
A complete response letter reflects FDA's complete review of the data submitted in an original application or abbreviated application (or, where appropriate, a resubmission) and any amendments that the agency has reviewed.
Response Letter means a written response to an Applicant addressing the Application, including whether all, none, or any part of the Application has been approved for inspection or production.