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USFDA draft guidance on : Cover Letter for Controlled Correspondences & ANDA Submissions

On December 10, 2021, the FDA published the draft guidance for industry entitled “Cover Letter Attachments for Controlled Correspondences and ANDA Submissions.”

This draft guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used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, as well as original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA.

These attachments do not replace the recommendations for the content of cover letters provided in other FDA guidances.

The cover letter attachments provided in this guidance have been developed by the disciplines that receive and respond to controlled correspondence and that assess ANDAs (including amendments and supplements). By publishing this guidance, FDA hopes to:

  • Provide greater clarity on the content and format of cover letters that accompany controlled correspondence, original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA

  • Improve the overall efficiency of the ANDA submissions process by ensuring these submissions are properly triaged and effectively managed by FDA and acted upon within the performance review goal dates set by GDUFA

FDA is issuing this guidance as part of our Drug Competition Action Plan (DCAP), which seeks to foster generic competition and help address the high cost of drugs.

Under DCAP, FDA 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.

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