The overall goal of this section is to provide the FDA with a comprehensive, factual overview of your non-clinical data [2]. Click through the Module 2.6 Non-Clinical Written and tabulated summary template below to learn more about how you can structure this section and convey all the key information needed for your product.
Pro Tip
Share all the current pharmacology and toxicology information that supports translation of the study from non-clinical to clinical and readiness for this IND submission.
The Module 2 sections provided below reflect the most typical study types conducted for AAV therapies. Other factors such as indication, on-target vs. off-target sites may require additional pre-clinical testing (e.g., reproductive toxicity). For other study types not listed below, please refer to FDA Guidance: The Comprehensive Table of Contents Headings and Hierarchy (fda.gov)
Module 2 | Summaries |
2.6 | Non-clinical Summary |
2.6.1 | Introduction |
2.6.2 | Pharmacology and Non-clinical Efficacy Written Summary |
2.6.3 | Pharmacology and Non-clinical Efficacy Tabulated Summary |
2.6.4 | Pharmacokinetics Written Summary* |
2.6.5 | Pharmacokinetics Tabulated Summary* |
2.6.6 | Toxicology Written Summary |
2.6.7 | Toxicology Tabulated Summary |
*Traditional pharmacokinetics (absorption, distribution, metabolism, excretion) studies are not feasible with AAV gene therapies. However, these sections are noted here for completeness per eCTD structure. These sections may be left blank.