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.