Guidance for pharma industry ANDA submissions issued by FDA

The US Food and Drug Administration yesterday published notice of the final guidance for industry Abbreviated New Drug Application submissions (ANDA).

This final guidance is intended to assist applicants in preparing complete and fileable ANDAs for submission to the 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 the 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, the FDA made technical clarifications and updated references in the final guidance so that it reflects the agency’s most current thinking.