Understand The R&D Process

Tips to Learn More

  • FDA has several resources that can help you learn more about the therapy development process. Although not specific to patient groups, the information is provided in an easy to understand manner:
    • How Does FDA Approve a Drug? provides a quick overview of the drug approval process in an animated 2 minute video. 
    • The Drug Development Process provides a basic overview of the approval process for drugs from discovery to postmarketing studies. The process is very similar for biologics. Each phase of the process has links to subsequent pages of more information. 
    • The Device Development Process provides a similar overview for medical devices.  
    • The Center for Drug Evaluation and Research (CDER)  Learn Training and Education offers educational and information modules about human drug regulation and activities through podcasts, education courses, and videos. 
      • Drug Approval: Bringing a New Drug to the Market , is a fictional case study navigating the drug approval process from conducting nonclinical testing and clinical trials to submitting a new drug application to FDA. It is in the form of an easy-to-read Fact Sheet. 
  • Global Genes , a nonprofit with the mission of connecting, empowering, and inspiring the rare disease community, provides several resources focused on the therapy development process.
  • European Patients’ Academy  is a website focused on education and training to increase the ability of patients to understand and contribute to medical research and development. This site includes online courses, webinars, and a searchable toolbox with over 3,000 resources.

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)