FDA Publishes Filing Checklists to Prevent Submission Delays

Sharan Murugan
7 hours ago
2 min read

In a pivotal move to reduce avoidable regulatory delays, On October 23, 2025 the FDA has made public the internal filing checklists used by the Center for Drug Evaluation and Research (CDER) to determine whether a submitted application—such as a New Drug Application (NDA) or Biologics License Application (BLA)—meets the threshold of being “complete and reviewable.”

By publishing these checklists, FDA aims to provide greater transparency, enabling sponsors to align better with agency expectations, avoid common submission pitfalls, and minimise the risk of a Refuse-to-File (RTF) decision.

A Refuse-to-File (RTF) decision occurs when the FDA determines that an application lacks essential components required for a full review under regulatory standards (21 CFR 314.101).

Why This Matters

Over the past decade, more than 200 applications submitted to CDER resulted in an RTF, a decision that halts the review clock and forces the sponsor to re-submit a complete dossier.
For NDAs involving new molecular entities that received an RTF, the average delay to resubmission was 426 days—more than a year of development time lost.
With the newly published checklists, sponsors have “no-surprise” guidance on what CDER expects at the initial filing stage, potentially reducing resource consumption and accelerating access to therapies.

According to the announcement, the public checklists derive from CDER’s MAPP 6025.4 Good Review Practices: Refuse to File, and cover multiple review disciplines.

Some of the key elements include:

Administrative completeness: correct forms, signatures, fees, and application jurisdiction.
Quality/CMC (Chemistry, Manufacturing & Controls): master file inclusion, batch data, stability, comparative data.
Nonclinical and clinical data modules: completeness of study reports, protocol definitions, patient exposure, endpoints.
Labeling and prescribing information drafts.
Benefit-risk rationale and overall summary.
Previous meeting minutes and regulatory commitments.

While detailed file names and contents might vary, the checklist gives sponsors a clear map of the “go/no-go” threshold before FDA begins formal review.

How Sponsors Should Use the Checklists

1. Pre-Submission Self-Audit

Before submitting an application, sponsors should use the relevant checklist as a self-audit tool, verifying that all pieces are present and properly formatted. A missing section can trigger an RTF.

2. Internal QA/QC Integration

Incorporate the checklist into your internal quality assurance workflows. Each discipline (CMC, nonclinical, clinical, labeling) should confirm readiness using the checklist before submission.

3. Clearing Files for Submission

Have designated team leads sign off on each domain checklist item, with timestamped tracking. This demonstrates governance and readiness if queried by FDA.

4. Post-Submission Tracking

Following submission, track any deficiency letters against checklist items to refine future submissions and maintain data integrity.

Filing checklists for Abbreviated New Drug Applications were published previously in MAPP 5200.14 Rev. 1.

The checklists are not exhaustive; FDA retains discretion to refuse to file based on legal or scientific grounds beyond checklist items. While the checklists help reduce procedural oversights, they do not guarantee substantive approval—they govern filing not substantive review.

For any company submitting an NDA or BLA in the coming months, access to these checklists offers a practical roadmap to increase filing readiness and reduce avoidable delay.