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

• 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

• View sample pages of a 510(k)
• View sample pages of an SS&E

Inspection Reports

• View a sample EIR
• View a sample 483
• View sample pages of company/FDA correspondence
• View a sample Warning Letter

Food Documents

• View sample pages from a Color Additive Petition
• View sample pages from a Food Additive Petition

Biologics Documents

• View sample pages from a biologic summary basis of approval
• View sample pages from a biologic 510(k)

Veterinary Documents

• View sample pages from a veterinary FOI Summary

Guidelines & Other FDA Documents

• View sample pages from advisory committee meeting minutes
• View sample pages from an advisory committee transcript
• View sample pages from a guidance manual
• View sample pages from a Warning Letter for a clinical investigator
• View sample pages from an internal FDA meeting