Drug Development Dashboard
Introduction & Methodology
Using publicly available data from review documents listed on Drugs@FDA, we created this dashboard to show how four expedited programs impact the time it takes for a drug or biologic to be approved. This dashboard displays data of 97 original therapeutic agents approved for use in oncology between January 1, 2013 & September 4, 2020. Supplemental approvals and supportive agents were excluded.
Time to approval was calculated as the time from submission of an Investigational New Drug Application (IND) to the date of approval. Time in development was calculated as the time from submission of an IND to the date FDA received the sponsor’s New Drug Application (NDA) or Biologics License Application (BLA). Time under review was calculated as the time from NDA/BLA submission to date of approval.
Please note the reviews for some drugs/biologics approved between January 2013 and September 2020 were not yet available online. These approvals were excluded from the dashboard and will be added as their review documents become available. This dashboard was last updated 11/4/2020 and will be updated on a quarterly basis beginning Q1 2021.
Interact with the dashboard elements to change the view. You can filter by year, expedited program, etc. Click the expedited/traditional approval number figure or select the dots in the “Time to Approval by Expedited Program” figure to see how each figure changes.
You can also reset the dashboard to show all approvals by clicking the “|<-“ on the bottom of the window.
You are welcome to submit feedback to firstname.lastname@example.org.