Thursday, 8 September 2022 9 .00 - 17.15 h
FDA has put into effect the internal Manual of Policies and Procedures MAPP 6030.9 on good review practices for applications submitted for new drugs (IND = investigational new drug applications) in April 2013.
This document is supposed to provide a consistent approach to the handling of submissions of INDs within the Center for Drug Evaluation and Research (CDER).
It clarifies the roles and responsibilities for the handling of IND submissions. It also describes the goal that CDER reviews the submissions timely insofar as the human resources permit this. Up to today the time for the handling of IND applications has not been fixed.
The processes described in this document are seen as dynamic. This means that these principles will evolve over time with feedback from applicants ("sponsors") and FDA reviewers ("review staff").
It is underlined that the sponsor is responsible for a well-organized and complete submission. Part of this are for example meaningful summaries that provide sufficient information on important data.
Table 1 on page 21 shows that the initial safety review is supposed to be completed in less than 30 calendar days. The further tables 2 and 3 summarise some of the topics that are often dealt with in the IND milestone meetings or in other important meetings (table 2 for nonbiosimilars and table 3 for biosimilars).
For further information please read the complete FDA document entitled "Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review".