FDA complete response letters
Complete response letters FDA has published, newest first: the applicant, the application and the letter date, each linked to FDA's own table.
2 on file
- 2026-08-07Complete response letter to ITM Solucin GmbHNDA 218705
- 2026-07-21Complete response letter to Apiject Systems Corp.NDA 219107
What a complete response letter is
A complete response letter tells an applicant that FDA has finished reviewing a drug or biologic application and will not approve it in its present form. The letter describes the deficiencies FDA found. FDA began publishing these letters in July 2025.
Questions
A complete response letter tells an applicant that FDA has finished reviewing a drug or biologic application and will not approve it in its present form. It lists the deficiencies the agency found and what would be needed to address them. FDA began publishing these letters in July 2025; before then only the applicant saw them.
Not finally. The applicant can resubmit the application with the deficiencies addressed, request a meeting with FDA, or withdraw. Many products that received a complete response letter were later approved on resubmission.