Understand The R&D Process

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)

From Molecules To Medicine: How Are New Drugs & Therapies Developed? 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)