Scientific knowledge steers the drug approval decision-making process of the Center for Drug Evaluation and Research (CDER).
FDA scientists conduct laboratory, clinical and statistical research to proactively address knowledge gaps created by advances in drug development and healthcare technologies, or to address safety questions that arise during post-market drug monitoring. Known as regulatory science, this research utilizes cutting-edge analytical tools and techniques to answer questions that apply directly to the evaluation of product safety, efficacy and quality.
CDER scientists use multi-disciplinary approaches that incorporate laboratory- and computer-based analytical methods to address regulatory questions. Their findings are presented to the scientific community through peer-reviewed manuscripts and at professional meetings.
Knowledge gained from CDER science and research increases the certainty and consistency of regulatory decisions, and contributes to the development of regulatory guidance documents and best practice standards for pharmaceutical companies.
CDER's Science and Research Programs
Strategic Plans and Reports About Science at CDER
|Paving the Way for Personlized Medicine (PDF - 854KB)||Safety Science and Research (PDF - 17.7MB)||CDER's Scientific Needs - July 2011||CDER's Drug Safety-Related Science Needs (SRIG) - March 2014 (PDF - 244KB)|