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.

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