Document Descriptions
The FOI Online library consists of over 85,000 drug, device, and other FDA related documents. Click on a document type below for a detailed description and sample document pages.
Drug Documents: Overview
- View a sample NDA approval letter
- View sample pages from a drug review
- View sample pages from a Summary Basis of Approval
- View a sample ANDA approval letter
- View a sample dissolution review
Device Documents: Overview
Inspection Reports: Overview
- View a sample EIR
- View a sample 483
- View sample pages of company/FDA correspondence
- View a sample Warning Letter
Food Documents: Overview
Biologics Documents: Overview
- View sample pages from a biologic summary basis of approval
- View sample pages from a biologic 510(k)