Article Summary:
The US Food and Drug Administration (FDA) has made public the internal checklists used by its staff when reviewing drug and biologics applications. This move is aimed at increasing transparency and reducing the number of incomplete submissions, which can lead to delays in the review process.
The published checklists are part of the FDA’s Manual of Policies and Procedures (MAPP) and outline the criteria for when the agency will issue a “refuse-to-file” (RTF) decision. The guide states that the FDA will RTF applications that are “materially incomplete or inadequately organized.”
Over the past ten years, more than 200 applications have received an RTF notification, with those involving a new molecular entity facing an average delay of 426 days before resubmission. The MAPP emphasizes the FDA’s expectation that applications be complete at the time of submission and that a “piecemeal approach” through amendments is unacceptable.
The guide provides examples of easily correctable deficiencies, such as issues with electronic navigation or missing references, as well as more complex and significant deficiencies, such as omitting application summaries or key data. The FDA also outlines how it will handle easily correctable RTF deficiencies, stating that they may be communicated through various means of communication.
Overall, the FDA’s move to make these checklists public is aimed at improving transparency and reducing delays in the review process, ultimately benefiting the development of new drugs and biologics.