FDA Issues Draft Guidance on Preparing Abbreviated New Drug Applications

The Food and Drug Administration June 11 released a draft guidance for industry intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for generic drugs.

A notice announcing the draft guidance will be published in the June 12 Federal Register.

The draft guidance, “ANDA Submissions—Content and Format of Abbreviated New Drug Applications,” summarizes the statutory and regulatory requirements for ANDAs, references existing guidance documents and incorporates additional recommendations on the content and format of ANDA submissions, the agency said.

The FDA also said the draft guidance describes the Common Technical Document (CTD) format for human pharmaceutical product applications ...