U.S. Department of Health and Human ServicesHHS National Institutes of HealthNIH National Center for Advancing Translational SciencesNCATS
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Understand The R&D Process

After FDA Market Approval

After a therapy receives approval from the FDA, there are still opportunities for your group to support the process, including collecting data to continue monitoring its safety and effectiveness and ensuring the new treatment is available as an option to all patients. 

  • Postmarket surveillance: The FDA has processes and programs in place to provide further monitoring of approved therapies. In some cases, the FDA will require a Phase 4 clinical trial as part of the marketing approval, or the Sponsor will include a Phase 4 clinical trial or other monitoring program, such as a long-term natural history study, as part of the NDA.
    • Phase 4 clinical trials: Postmarket studies are conducted after a therapy has received FDA marketing approval to provide additional information including the treatment or drug’s risks, benefits, and best use. 
  • NCATS Toolkit provides information about ways your group can support postmarket surveillance and other key areas in After FDA Approval. Other key areas after FDA marketing approval include:
    • Ensuring patients are correctly and quickly diagnosed, so the new therapy is available to them.
    • Updating or developing clinical care guidelines.
    • Working with medical insurance providers to reimburse patients for the newly approved therapy.

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)