Download Approved CRLs – 2020 to 2024 (external link)

U.S. Food and Drug Administration (FDA) has, for the first time, made publicly available a centralized database of Complete Response Letters (CRLs) issued between 2020 and 2024. These documents, previously confidential, are now accessible for public scrutiny, offering insights into the FDA’s decision-making process for both New Drug Applications (NDAs) and Biologics License Applications (BLAs) that did not receive approval in their current form.

Download Approved CRLs – 2020 to 2024 (external link)

What Are Complete Response Letters?

A Complete Response Letter is the FDA’s formal communication to a drug sponsor indicating that an application cannot be approved in its current form. Rather than a simple rejection, a CRL provides detailed reasoning, outlining the deficiencies that must be addressed before the application can proceed. These may include:

• Efficacy and safety concerns

• Manufacturing and quality control issues

• Clinical trial design or data inadequacies

• Labelling or packaging inconsistencies

• Failure to demonstrate substantial evidence of benefit

CRLs represent a critical checkpoint in the FDA’s commitment to safeguarding public health while encouraging sponsors to rectify shortcomings with clarity.

Why This Matters: Industry and Public Benefits

The release of historical CRLs opens unprecedented opportunities for stakeholders:

• For drug developers: Access to past CRLs can help companies understand common pitfalls, align trial designs with regulatory expectations, and anticipate areas of scrutiny during submission.

• For investors: Transparency into why certain products failed approval can inform better risk assessments and pipeline evaluations.

• For healthcare professionals and patients: This initiative bolsters trust in regulatory processes and drug safety oversight.

“By publishing these letters, we are enhancing the transparency of FDA’s review process and supporting a culture of regulatory learning,” said Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER).

Download Approved CRLs – 2020 to 2024 (external link)

How to Use the CRL Database

Each record contains:

• Application number

• Sponsor name

• Issue date

• Summary of deficiencies

• Therapeutic category

Researchers, sponsors, and consultants can filter by year, disease area, and sponsor to trace regulatory reasoning patterns.

The publication of CRLs represents a bold step toward constructive accountability and scientific dialogue. As the pharmaceutical and biotech industries face increasing complexity and scrutiny, this database offers a valuable learning tool to improve future submissions, accelerate innovation, and reduce costly regulatory setbacks.

By making the unseen visible, the FDA reinforces its commitment to evidence-based regulation, public health protection, and industry advancement.