Business · 13/12/2021Updated: 10/17/2026 · 1 min read

FDA Releases Draft Guidance for Industry on Cover Letter Attachments for Controlled Correspondences and Abbreviated New Drug Application Submissions

The Food and Drug Administration (FDA) has made available a draft guidance document to help applicants and holders of abbreviated new drug applications (ANDAs) prepare cover letter attachments for submissions to the Office of Generic Drugs (OGD) and other FDA-regulated documents.