Cover Letter Attachments for Controlled Correspondences and Abbreviated New Drug Application Submissions; Draft Guidance for Industry; Availability

概要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Cover Letter Attachments for Controlled Correspondences and Abbreviated New Drug Application Submissions.''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 to the Office of Generic Drugs (OGD), as well as original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA.