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

On September 24 , 2018, FDA published notice of the final guidance for industry entitled “ANDA Submissions - Content and Format of Abbreviated New Drug Applications.”   This final guidance is intended to assist applicants in preparing complete and fileable abbreviated new drug applications (ANDAs) for submission to FDA. It details the information to 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. After considering public comments submitted to the docket for the draft version of the guidance, published in June 2014, FDA made technical clarifications and updated references in the final guidance so that it reflects the agency’s most current thinking.  FDA is publishing this final guidance as part of the Commissioner’s Drug Competition Action Plan, which lays out the agency’s plans to streamline the ANDA assessment process, provide clarification and assistance to current and prospective applicants, and, ultimately, expand access to lower cost, high quality medicines. Direct link to the guidance: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM400630.pdf