The U.S. Food and Drug Administration (FDA) has taken a major step toward improving transparency and efficiency in the drug approval process with the release of its New Drug Application (NDA) filing checklist. The tool, included in an updated Manual of Policies and Procedures (MAPP 6025.4), aims to reduce incomplete submissions and prevent costly delays in reviewing new drug and biologics applications.
Enhancing Transparency and Accountability
According to FDA Commissioner Marty Makary, the initiative reflects the agency’s goal of making the submission process more transparent and predictable. “Drug applications should not be derailed or delayed by preventable procedural oversights,” Makary said. “Making these checklists public is a common-sense step to make the FDA process easier to understand and more transparent.”
The checklist provides sponsors with detailed criteria for submission completeness—criteria that FDA reviewers already use internally to determine whether an application is ready for formal review or subject to a Refuse-to-File (RTF) decision. By making these internal tools public, FDA aims to help sponsors better prepare their applications before submission, saving time and resources for both applicants and reviewers.
Addressing a Persistent Problem
Over the past decade, more than 200 applications have received RTF notifications due to deficiencies in content or organization. For applications involving new molecular entities, these RTFs have caused average delays of up to 426 days before resubmission.
The updated MAPP outlines FDA’s expectation that applications be complete at the time ofsubmission, rejecting “piecemeal” filings that rely on later amendments to fill gaps. The checklist also describes the responsibilities of key review personnel—discipline reviewers, team leaders, and project managers within the Center for Drug Evaluation and Research (CDER)—to ensure a consistent approach across all submissions.
Understanding the Deficiency Categories
The FDA distinguishes between “easily correctable” and “complex or significant” deficiencies.
- Easily correctable issues include missing forms (such as FDA 356h or 3454), incomplete references, minor electronic navigation errors, or formatting issues. These can typically be resolved quickly via phone or email communication between sponsors and FDA staff.
- Complex deficiencies, however, include missing summaries, incomplete chemistry, manufacturing, and controls (CMC) sections, or gaps in clinical pharmacology and toxicology data—issues that can trigger an immediate RTF decision.
CDER will also use discipline-specific standard filing templates for biostatistics, product quality, and clinical pharmacology reviews. These templates are designed to promote consistency and help reviewers identify deficiencies early in the filing process.
Reducing Review Delays and Improving Efficiency
The release of these checklists marks a significant improvement in the agency’s approach to regulatory efficiency. By clearly communicating expectations upfront, FDA hopes to reduce administrative backlogs and accelerate patient access to new therapies. The initiative also supports the agency’s broader efforts to modernize review procedures through greater use of standardized documentation, digital communication, and early engagement with sponsors.
The EMMA International Perspective
At EMMA International, we view this move as an important step toward harmonizing transparency, quality, and efficiency in regulatory submissions. As the FDA continues to emphasize completeness and data integrity, life-science organizations must ensure that their submissions are not only scientifically sound but also administratively robust.
Our regulatory experts help clients navigate complex submission requirements by developing compliant documentation strategies, verifying data integrity, and aligning with FDA expectations from the earliest stages of product development.
Effective preparation is key to avoiding costly RTF outcomes—and to ensuring that innovative therapies reach patients faster.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
U.S. Food and Drug Administration. (2025, October 23). FDA publishes NDA filing checklist to avoid application derailments. https://www.fda.gov
Eglovitch, J. (2025). FDA publishes NDA filing checklist to avoid application derailments. Regulatory Focus.
