CTD Section 2.7.1 Report
Summary
Section Name:
Summary of Biopharmaceutic Studies and Associated Analytical Methods
Section Code:
2.7.1
Module Number:
2
Description:
This section should provide the reviewer with an overview of the formulation development process, including specific results on individual studies (tables and figures), narrative descriptions of critical design features and critical results. Lengthy tables should be attached at the end of the document, smaller tables and figures can be embedded in the text to enhance comprehension
Submission Timing
As early as initial IND application (see note), completed by marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources