Bantam Receives Filing Letter from FDA
Bantam Vape moves forward to next step in PMTA process
In our most recent blog post, we announced the acceptance of our PMTA application by the U.S. Food and Drug Administration. We are now excited to share the latest development in our application’s journey—our application has formally been “filed” by the FDA.
In short, we’ve received a filing letter from the FDA letting us know that their preliminary review of our PMTA is complete.
From here, our application moves to the next step of the process and undergo a formal substantive review. In this next stage, the FDA will conduct an in-depth evaluation of the scientific studies and data we submitted with our PMTA.