Understand The R&D Process
FDA Review and Approval
After completion of the first 3 phases of clinical trials, the Sponsor analyzes the data. If the data shows that the therapy is effective and safe, the company submits a New Drug Application (NDA) to the FDA. Your group may wish to become a member of the FDA Advisory Committee if one is needed during the review process.
- An NDA will contain:
- Data from all the preclinical and Phase 1, 2 and 3 studies, plus analyses of that data.
- Information about how the therapy is produced.
- Review of an NDA can take up to 1 year. The FDA:
- Establishes that the data demonstrates that the therapy is both safe and effective.
- Weighs the benefits and potential risks of the therapy.
- Decides what information should be included in the package insert to instruct doctors about how to use the therapy and for which patients.
- Ensures that the therapy will be manufactured to the highest quality.
- If the data cannot be clearly interpreted to grant approval or disapproval, the FDA may decide to have an FDA Advisory Committee review the evidence in a public meeting to gain additional perspectives to include in their decision making process.
- NCATS Toolkit provides more information on FDA Advisory Committees in Clinical Trials and FDA Review: Participate in the FDA Advisory Committee Meetings.
- If the therapy is approved, then manufacturing on a large scale begins and the drug can be sold to patients outside of clinical and research studies.