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FDA issues guidance documents to assist applicants in preparation of ANDAs


In September 2018, content and format guidance for the industry was provided to prepare ANDA submissions

The guidance details the information that should be provided in each section of the common technical document (CTD) format for human pharmaceutical product applications and identifies supporting guidance documents and recommendations issued by FDA to assist applicants in preparing their ANDA submission.

This guidance identifies the information that an applicant should include to ensure that a complete, high-quality application is submitted to FDA. FDA has previously published guidance documents on the filing process, including the guidance for industry about refuse-to-receive standards, and common, recurring deficiencies which should be reviewed thoroughly prior to submission of an ANDA.

FDA has issued several guidance documents specific to the CTD and eCTD submissions. The information contained in these guidances focuses on the technical aspects of filing a CTD application and should be reviewed thoroughly prior to submitting an ANDA. This guidance, however, specifically addresses the content of the CTD for an ANDA.

The sections that follow in this guidance provide additional detail about the information that should be submitted in the applicable modules, sections, and subsections.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, the guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidances means that something is suggested or recommended, but not required.

One can view the entire guidance document at

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