Back to Science & Research (Drugs)
The Center for Drug Evaluation and Research (CDER) employs scientists and physicians from a broad range of disciplines who protect public health by speeding the development of medicines while ensuring that the drugs are safe and effective. These scientists' work runs the gamut of scientific research, from basic science in the laboratory to clinical studies with patients.
Regulatory scientists at CDER:
- Conduct their own clinical studies and review clinical studies originating outside FDA to assess the safety, effectiveness, and quality of regulated drugs
- Conduct laboratory experiments to understand how drugs work at the molecular and cellular levels and to devise new methods for testing drugs' properties.
- Conduct studies to determine how to ensure the quality of manufactured drugs and biologics
- Use statistical and mathematical methods to enhance drug evaluation (e.g., by helping develop new clinical trial designs)
- Apply advanced modeling and simulation approaches to predict how drugs will act in populations for whom there are limited data
- Advance innovative computational approaches to address drug safety issues by analyzing “Big Data”
- Work collaboratively with industry, academia, and other stakeholders to address challenges in drug development and to provide guidance to foster drug development programs and improve their outcomes
Read interviews with some of CDER's scientists about their research and experiences as scientists at FDA.
The scientists who work at CDER include:
- Chemists: Learn more about the work analytical chemists do on therapeutic proteins at CDER.
- Clinical pharmacologists: Learn more about what clinical pharmacologists do at CDER.
- Computer scientists
- Pharmaceutical analysts: Learn more about what pharmaceutical analysts do at CDER.
- Social and behavioral scientists
- Statisticians: Learn more about what biostatisticians do at CDER.