FDA Publishes New Filing Checklists to Prevent Drug Submission Delays
On October 23, 2025, the FDA announced the publication of new filing checklists designed to help drug sponsors avoid submission delays for both New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs)9.
These checklists specify all necessary criteria and documentation required for a complete drug application, aiming to reduce the frequency of Refuse-to-File (RTF) and other administrative rejections that can delay drug approvals5.
The new guidance outlines the roles of FDA discipline primary reviewers in assessing NDAs and provides criteria for when the FDA will issue an RTF, thus giving sponsors a clearer understanding of expectations5.
By standardizing requirements, the FDA aims to increase review efficiency and transparency, empowering applicants to address common mistakes before submission and thereby prevent unnecessary regulatory delays65.
This initiative is part of wider FDA efforts in 2025 to promote transparency, as the agency also began publishing previously unpublished complete response letters detailing specific deficiencies in submissions to help sponsors learn from past application issues26.
Detailed and up-to-date versions of these new checklists are available directly from the FDA's official resources and are expected to become a routine part of the submission workflow for drug sponsors53.
Sources:
2. https://www.fda.gov/news-events/press-announcements/fda-announces-real-time-release-complete-response-letters-posts-previously-unpublished-batch-89
3. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/abbreviated-new-drug-application-anda-forms-and-submission-requirements
5. https://www.raps.org/news-and-articles/news-articles/2025/10/fda-publishes-nda-filing-checklist-to-avoid-applic
6. https://www.appliedclinicaltrialsonline.com/view/new-fda-initiative-reveals-common-reasons-drug-application-rejection
9. https://www.fda.gov/news-events/fda-newsroom/press-announcements