Who We Are:
The Office of the Center Director provides leadership and overall direction to all CDER activities to ensure that the mission of the Center is accomplished. CDER makes sure that safe and effective drugs are available to improve the health of consumers. CDER ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks.
What We Do:
- Identify, track, oversee, and establish policies regarding the management of important drug safety issues.
- Track emerging safety issues and ensuring that they are resolved in a timely manner.
- Provide scientific and regulatory leadership and guidance for responding to public health emergencies involving drugs that may pose an immediate threat to the public health.
- Develop, communicate, implement and assess advocacy and stakeholder relations strategies.
- Collaborate with the public and private sectors to address issues of interest, including strategies for ensuring safe medication. use.
- Lead the Center’s drug development initiatives related to terror and military counter-terrorism measures.
- Lead CDER responses to public health emergencies (e.g., pandemic influenza, and disasters) or to counteract the effects of a terrorist event.
- Facilitate the development and availability of medical countermeasures to chemical, biological, and other threats.
- Develop policies and procedures governing the management and prevention of drug shortages.
- Office of the Center Director Immediate Office
- Controlled Substance Staff
- Drug Safety Oversight Board
- Professional Affairs and Stakeholder Engagement
- Drug Shortage Staff
- Counter-Terrorism and Emergency Coordination Staff
Email: CDERCENTERDIRECTOR@fda.hhs.gov | Telephone: 301-796-5400 | Fax: 301-595-7910
Office of the Center Director, Center for Drug Evaluation and Research, White Oak Building 51, 6th Floor, 10903 New Hampshire Avenue, Silver Spring, MD 20993