What To Expect During The NDA Review Process

Compiling and submitting a New Drug Application (NDA) is a complex and intensive endeavor, requiring meticulous attention to detail and extensive documentation. After submitting your application to the FDA, it's natural to wonder what you can anticipate in terms of feedback and timelines. Understanding the NDA review process can help manage expectations and prepare for the next steps.

Below, we address some of the most frequently asked questions from sponsors regarding what to expect during the NDA review process.