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ANDA Submissions: Content and Format Guidance for Industry

This comprehensive guidance document, published by the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), provides essential information for industry professionals on preparing Abbreviated New Drug Applications (ANDAs).

Issued in September 2018 by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), the document details the structure and content requirements for ANDA submissions, primarily focusing on the Common Technical Document (CTD) format.

The guidance aims to assist applicants in ensuring complete and high-quality submissions, covering various modules of the CTD format, including administrative information, summaries, quality, nonclinical, and clinical study reports.

Additional copies and related information can be accessed via the FDA's official website:

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