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USFDA Guidance: Cover Letter Attachments for Controlled Correspondences & ANDA Submissions

The United States Food & Drug Administration published the final guidance "Cover Letter Attachments for Controlled Correspondences and ANDA Submissions" earlier today (June 5, 2023).


A controlled correspondence is a communication submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element of generic drug product development or certain postapproval submission requirements.

The purpose of this guidance is to provide prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used when preparing cover letters to accompany controlled correspondence submitted to the Office of Generic Drugs (OGD), including original ANDAs, amendments to ANDAs, and supplements to approved ANDAs.


An overview of the submission is provided in the cover letter so FDA can triage and assign the submission correctly. A cover letter is generally included with controlled correspondence to the Office of Generic Drugs (OGD) and submissions to an ANDA file.


Applicants are encouraged to follow the recommendations in this guidance when preparing cover letters for controlled correspondence and ordinary ANDA submissions to help ensure they include pertinent information that will assist FDA in evaluating the submission.


The cover letter attachments are designed as a checklist of information that applicants are expected to include in their cover letter, and they are intended to serve as a guide to help applicants prepare their cover letters as well as to assist FDA in triaging and managing submissions.


Click this LINK to know in detail about the Cover Letter Attachments for Controlled Correspondences & ANDA Submissions.


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