Module 2.2: Introduction to Summaries
In this section, you will be providing the FDA with a summary of the development plans, non-clinical and any clinical data obtained on the investigational product. Ideally, the introduction should include basic information like proprietary, nonproprietary, and common names of your product, company name, formulation of the dosage form, strengths, route of administration, and proposed indications.
Consider following the sample outline below while structuring your introduction based on the information you have available:
Product Name
Product Description
Active Ingredients
Pharmacological Class
Proposed Indication
Formulation of the Dosage Form
Route of Administration
Clinical Program Objectives
Planned Duration of the Proposed Clinical Study
References