On June 5, 2023, FDA published the guidance for industry titled “Cover Letter Attachments for Controlled Correspondences and ANDA Submissions,” which was published as a draft in December 2021. This guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used when preparing cover letters that accompany controlled correspondence to the Office of Generic Drugs (OGD), as well as original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA.
Cover letters provide an overview of a submission and help FDA ensure that the submission is properly triaged and assigned to the appropriate assessors. In an effort to ensure that submissions are effectively managed by FDA and acted upon within the performance revew goal dates agreed to in the GDUFA III commitment letter, FDA has developed cover letter attachments to accompany, or assist in the preparation of, applicants’ cover letters for the common submissions listed above. These attachments do not replace cover letters.
These cover letter attachments have been designed as a checklist to reflect common types of information applicants are expected to address in their cover letters. The attachments are intended to serve as a useful guide to help applicants prepare their cover letters and to assist FDA in the triage and management of submissions.
FDA published this guidance as part of its GDUFA III commitments and in support of the Drug Competition Action Plan (DCAP), which seeks to foster generic competition and help address the high cost of drugs. Through DCAP, FDA is committed to enhancing the efficiency of the development and approval of ANDAs, with the ultimate goal of more approvals, thereby helping to increase access to high-quality, lower cost generic drugs.
Additional Resources
Controlled Correspondence – Resources for correspondence 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 post-approval submission requirements
ANDA Forms and Submission Requirements – Summary tables, application forms, question-based review, and other resources related to ANDA submissions
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