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FDA Guidance for Industry: ANDA Submissions — Content and Format of Abbreviated New Drug Applications

This guidance is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). This 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 deficiencies4 which should be reviewed thoroughly prior to submission of an ANDA.

 

Posted on the FDA website on 12 June 2019

2019-06-17T22:15:11+00:0017.06.2019|Regulatory Affairs, Training|