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:
- Discovery or developing a therapeutic approach.
- Preparing for clinical trials, including preclinical studies.
- Clinical trials.
- FDA review and marketing approval.
- Postmarket approval.
Resources
Preparation for Clinical Trials
FDA Guidance for Industry: Good Laboratory Practices Questions and Answers
U. S. Food and Drug Administration (FDA) (link)
Developing Products for Rare Diseases & Conditions
U. S. Food and Drug Administration (FDA) (link)
Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review
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)
Drug Development Road Map
Global Genes (link)
The 10 Things You Need to Pursue Research For Your Disease: What Are the Options for Research and Why is it so Hard?
Global Genes (link)
European Patients' Academy
European Patients' Academy on Therapeutic Innovation (link)