Understand The R&D Process

Overview

The development of new therapies for any disease can be loosely categorized into different stages, with the final goal of a therapy being approved by the U.S. Food and Drug Administration (FDA) for marketing. Because the stages—and the components within each stage—are not necessarily linear, you may find that your patient group already has completed some of the important pieces in the process or that some of the pieces may not be necessary for your disease. Understanding the whole process can help you develop an overall plan of the best approach for your group to engage in the therapy development process. 

From a patient group perspective, the stages to develop new therapies may be organized into: 

Resources

Preparation for Clinical Trials
Developing Products for Rare Diseases & Conditions U. S. Food and Drug Administration (FDA) (link)
Tips to Learn More
How Does FDA Approve a Drug U. S. Food and Drug Administration (FDA) (link)
The Drug Development Process U. S. Food and Drug Administration (FDA) (link)
The Device Development Process U. S. Food and Drug Administration (FDA) (link)
CDER Learn Training and Education U. S. Food and Drug Administration (FDA) (link)
Drug Approval: Bringing a New Drug to the Market U. S. Food and Drug Administration (FDA) (link)
European Patients' Academy European Patients' Academy on Therapeutic Innovation (link)