Atlas Analytics · Complete response letters
Complete Response Letter (CRL) analytics: why FDA applications get refused
An FDA complete response letter (CRL) tells a sponsor that its drug or biologic application cannot be approved in its current form. In Atlas's dataset of published letters, the FDA issued 65 CRLs in 2024, 48 in 2025 and 17 in the first half of 2026. Facility inspection problems appear in 42 of the 65 letters from 2024.
Atlas analysis of FDA complete response letters published through openFDA · letters dated 2009 to June 2026 · figures read October 14, 2026
Complete Response Letter (CRL)
65
CRLs in 2024
48
CRLs in 2025
42 of 65
2024 CRLs citing facility inspections
44
2024 CRLs for NDAs
Complete response letters by year
* 2026 covers letters dated January to June.
Why 2024 CRLs were issued
- Clinical56
- Facility inspections42
- Clinical pharmacology11
- Device related5
Product quality, labelling, nonclinical and more
A letter can cite more than one category.
CRLs by application type
- NDA, 202444
- BLA, 202421
- NDA, 202528
- BLA, 202520
CRLs by FDA approval office
In the complete dashboard
Which review divisions issue the most letters, from oncology to neuroscience.
Deficiency sub-themes and GxP domain
In the complete dashboard
The recurring sentences behind each refusal, grouped by theme and GxP area.
Complete dashboard
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- Every year of letters from 2008
- All rejection categories, including product quality and labelling
- CRLs by FDA approval office
- Deficiency sub-themes and GxP domain
- The full written analysis of the letters
What is an FDA complete response letter?
A complete response letter is the FDA's formal decision that a new drug application (NDA) or biologics license application (BLA) cannot be approved as submitted. It lists the deficiencies the sponsor must fix. The sponsor can resubmit, withdraw the application or request a hearing.
Since July 2025 the FDA has published complete response letters through openFDA, which made a dataset like this possible. 2024 had the most letters in the record, with 65.
| Year | NDA | BLA | Total |
|---|---|---|---|
| 2024 | 44 | 21 | 65 |
| 2025 | 28 | 20 | 48 |
| 2026, January to June | 10 | 7 | 17 |
Why the FDA refuses applications
Clinical deficiencies appear in 56 of the 65 letters from 2024, and facility inspection problems in 42. That second number is the one most quality teams can act on: a site that is not ready for a pre-approval inspection holds an application back even when the science is sound. Our guide to pre-approval inspections and our analysis of CRLs and facility readiness cover how to prepare.
A Form 483 from the pre-approval inspection is often the root of a facility deficiency. You can check a manufacturing site's inspection history in the FDA-inspected facilities directory before you file.
| Category | 2024 letters |
|---|---|
| Clinical | 56 |
| Facility inspections | 42 |
| Clinical pharmacology | 11 |
| Device related | 5 |
Frequently asked questions
What is a complete response letter from the FDA?
It is the FDA's notice that a drug or biologic application cannot be approved in its current form. The letter lists every deficiency, from clinical data gaps to facility inspection findings, and the sponsor decides whether to resubmit, withdraw or request a hearing.
How many complete response letters does the FDA issue each year?
In Atlas's dataset of published letters, the FDA issued 65 CRLs in 2024, 48 in 2025 and 17 in the first half of 2026. 2024 is the highest year in the record.
What are the most common reasons for a CRL?
Clinical deficiencies are the most common, cited in 56 of the 65 letters from 2024. Facility inspection problems come second, in 42 letters, followed by clinical pharmacology and device issues. Most letters cite more than one reason.
Can a company resubmit after a complete response letter?
Yes. The sponsor can resubmit with the deficiencies addressed. For NDAs and BLAs the FDA classifies a resubmission as Class 1, with a two-month review goal, or Class 2, with a six-month goal, depending on how much new information it contains.
Are FDA complete response letters public?
The FDA began publishing complete response letters through openFDA in July 2025, including letters for applications that were later approved. Atlas classifies those letters by category, sub-theme and GxP area. Enter your work email above to request the full analysis.