FDA-TRACK: Center for Drug Evaluation and Research - Policy and Science Development Dashboard

 

Subscribe to FDA-TRACK Updates

 

Menu

Policy and Science
Development

• • Policy and Science Development Dashboard

Pre-Approval Safety
Review

• • Drugs and Biologics Dashboard
• • Biosimilars Dashboard
• • Generics Dashboard

Post-Approval Safety
Monitoring

• • Drug Shortages Dashboard
• • Compliance Dashboard
• • Patient Safety Tools Dashboard

Relevant Links:

• • Guidance Development
• • Scientific Publications by FDA Staff
• • Advisory Committees

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.

Researchers at CDER focus on developing the scientific knowledge, methods, tools, and standards needed to develop and evaluate new drugs. In this effort, CDER also engages the wider research community in collaborative research to address critical gaps in CDER’s scientific knowledge that hinder drug development. At public meetings, CDER staff obtain vital information from patients to identify and address unmet medical needs. The new knowledge and capabilities obtained through these efforts, and the opportunities they provide to further drug development, are communicated to sponsors and the wider scientific community through scientific guidances, peer-reviewed publications, and a variety of formal and informal meetings, including scientific workshops and advisory committees.

 

 

Download Policy and Science Development Dataset PDF / Print Version

---

Footnotes:

1. 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 Policy and Science Development Dataset" located right below the visualizations. 
2. Scientific Publications by FDA Staff is intended for retrieving detailed information for individual publications.
3. As of 2018, these numbers do not include 'epubs ahead of print' publications to prevent double counting if and when the print version is added to the FDA's publications database.