Cover Letter Attachments for Controlled Correspondence and ANDA Submissions Guidance for Industry

“The format of the cover letter attachment can be customized by the applicant according to their convenience. The primary purpose of the cover letter attachment is to assist applicants in ensuring that they address relevant information in any cover letter they submit to the FDA for the submissions mentioned in this guidance.

The cover letter attachments serve as a checklist to encompass the common types of information that applicants are expected to include in their cover letters for their submissions. These cover letter attachments have been created by the divisions responsible for receiving and responding to controlled correspondence and evaluating ANDAs, including amendments and supplements.

While it is not mandatory for applicants to include an attachment with their cover letter, the optional cover letter attachment can serve as a helpful guide to assist applicants in preparing their cover letters, especially in situations outlined in Appendices 2 and 3.”

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