FDA-TRACK: Center for Drug Evaluation and Research - Pre-Approval Safety Review - Drugs and Biologics Dashboard
Policy and Science
Development
Pre-Approval Safety
Review
Post-Approval Safety
Monitoring
FDA’s Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. CDER also regulates other non-medicines that are considered to be drugs like fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens. CDER protects and advances public health by ensuring safe and effective drugs are available to improve the health of people in the United States.
Prior to approval, new drugs go through many steps, or “phases” during the approval process. They are first tested on animals, then on small groups of humans for preliminary safety information (phase 1) and again on small groups of people to get a preliminary review of the drug’s effectiveness (phase 2). Very few drugs make it past these early phases, as companies and/or CDER often find early signs that the drug may not be as safe or effective enough. For the relatively few drugs that pass these hurdles, phase 3 clinical trials are the next step. Generally, this phase involves a much larger group of people. Clinical trial patients take the drug over an extended period of time under the supervision of scientists and health care professionals who assess the overall risks and benefits of the drug. Drugs that still show potential for safety and effectiveness after phase 3 trials are the ones that FDA considers for approval. It is important to note that FDA is not responsible for conducting clinical trials. It assesses the data from clinical trials to evaluate drugs during the approval process.
Data contained in the dashboard is not final, but accurate at the time of posting; refer to the PDUFA Performance Reports to Congress for official data.
Download Drugs and Biologics Dataset PDF / Print Version
Footnotes:
- Data collection began with FY2016 submissions.
- Figures provided are Filed and Pending Filing figures (not Submitted) and exclude those submissions that are Refuse to File (RF), Withdrawn Before Filing (WF), or Unacceptable Due to Nonpayment of User Fees (UN). Pending filing refers to those submissions that have not yet reached the 60-day filing date.
- Figures include NDAs and non-biosimilar BLAs.
- Counts for Priority, Standard and Unknown review, as well as novel drugs, Breakthrough and Fast Track, include both NDA and non-biosimilar BLA submissions, and are subsets of the number of original NDAs and non-biosimilar BLAs.
- Original submissions do not include NDAs with a Type 9 designation or an Efficacy Submission Class Code designation.
- Breakthrough and Fast Track properties are set by the choice question responses at filing.
- Approval data includes full approval and tentative approval actions taken on the original application and does not include efficacy supplements.
- Meeting data represents industry requested meetings that are scheduled with CDER.
- Type B(EOP) meetings were newly created under PDUFA VI and, therefore, have no data prior to FY2018.
- Number of WRO meetings scheduled include Type B(EOP) WRO meetings beginning in FY2018.
- Percentage of actions within goal includes actions on original submissions and resubmissions of the original application. This figure does not include actions on efficacy supplements.
- Number of new commercial INDs received.
- The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. The data presented in the visualizations above can be accessed by clicking on the link labeled "Download Drugs and Biologics Dataset" located right below the visualizations.
- Data contained in the dashboard is not final, but accurate at the time of posting.