Similar to Module 2.5, this section (Module 2.7) will not be required for the majority of original INDs for the same reasons
Do you have clinical data for your product?
Yes: This section is applicable!
Not applicable: Proceed to Module 3: Quality
The overall goal of this section is to provide the FDA with a comprehensive, factual overview of the clinical data for your product. You should consider including information about any prior investigations or marketing (US or globally) that has been done with your product, list the countries where your product has been marketed and whether it was withdrawn or state if there has been no prior human experience. Additionally, you need to ensure that this section is between 50-400 pages. [1]
To get more information about how you can structure this section and convey all the key information needed for your product, consider structuring this section based on the sample outline below:
Sample outline for clinical summary
1. Summary of Biopharmaceutic Studies and Associated Analytical Methods
In this section, your goal is to provide the FDA with an overview of the formulation development process, in vitro and in vivo dose determination information, the general approach, and rationale used in developing the bioavailability (BA), comparative BA, bioequivalence (BE), in vitro dissolution profile database, and analytical methods used. Consider the following flow:
1.1. Background and Overview
1.2. Summary of results of individual studies
1.3. Comparison and analysis of results across studies
Avoid including detailed information about individual studies here
2. Summary of clinical pharmacology studies
In this section, your goal is to provide the FDA with a summary of the clinical pharmacology studies including pharmacokinetics (PK), pharmacodynamics (PD), and human biomaterial database. Consider the following flow:
2.1. Background and Overview
2.2. Summary of Results of Individual Studies
2.3. Comparison and Analyses of Results Across Studies
Avoid including detailed information about individual studies here
3. Summary of clinical efficacy
In this section, your goal is to provide the FDA with a description of the controlled studies that were conducted to test efficacy (including: dose-response, comparative efficacy, and long-term efficacy). Consider the following flow:
3.1. Background and Overview
3.2. Summary of Results of Individual Studies
3.3. Comparison and Analyses of Results Across Studies
3.4. Analysis of Clinical Information Relevant to Dosing Recommendations
3.5. Persistence of Efficacy and/or Tolerance Effects
Avoid including detailed information about individual studies here
4. Summary of clinical safety
In this section, your goal is to provide the FDA with a summary of any data relevant to safety in the intended patient population. You can also incorporate your findings from the individual clinical study reports and other relevant reports within this section. The safety profile of your product should be outlined clearly and in an objective manner. Consider the following flow:
4.1. Exposure to the Drug
4.2. Adverse Events
4.3. Clinical Laboratory Evaluations
4.4. Vital Signs, Physical Findings, and Other Observations Related to Safety
4.5. Safety in Special Groups and Situations
4.6. Post Marketing Data
5. Literature references
In this section, your goal is to include all the publications cited in the clinical summary. Any references need to include their full copies in the literature section.
6. Synopses of individual studies
In this section, it is recommended that you include a study synopsis of each relevant clinical study on the drug.