Submission for FDA approval: New drug application (NDA)

In the United States, when clinical trials show a new drug treatment is more effective and/or safer than the current standard treatment, a new drug application (NDA) is submitted to the Food and Drug Administration (FDA) for approval. The FDA then reviews the results from the clinical trials and other relevant information. If the FDA has questions, it may ask for more information or even require that more studies be done. This can extend the approval process to more than 5 years.

Based on its review, the FDA decides if the treatment is OK to be used in patients with the type of illness the drug was tested on. If it is, the new treatment often becomes the standard of care, and newer drugs must then be tested against it before being approved.