Cover Letter Attachments for Controlled Correspondence and Abbreviated New Drug Application Submissions; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Cover Letter Attachments for Controlled Correspondence and ANDA Submissions." This guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used when preparing cover letters that accompany controlled correspondence, original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA. This guidance finalizes the draft guidance of the same title issued on December 13, 2021.