After FDA Approval

After approval of a therapy, your group can support continued safety and effectiveness monitoring and ensure the new therapy is available as an option for the approved patient population.  

After the FDA approves a new therapy, it must be integrated into clinical care for your disease. Because it’s not possible to predict all of a treatment’s effects during clinical trials, safety monitoring after a therapy is on the market is critical. The FDA may even require studies after the therapy is approved to help assure continued safety and effectiveness. In addition, your group can also focus your efforts on making sure patients are diagnosed as soon as possible and that the new treatment is accessible to all who need it.

Post-approval also includes research to identify new clinical questions and gaps in care, especially if the therapy is not a cure or only helps a specific subpopulation of your disease community. In fact for many groups, approval of one therapy means shifting more of your efforts to other potential treatments that are currently at an earlier stage of therapy development. Therefore, you may wish to review earlier topics in NCATS Toolkit to identify new opportunities and strategies to continue to drive therapy development for your disease. You are also encouraged to share with us any helpful resources, tips, or strategies from your group’s therapy development experience for possible inclusion in NCATS Toolkit through our Contact Page