Office of the Chief Scientist
The Office of the Chief Scientist provides strategic leadership, coordination, and expertise, supporting scientific excellence, innovation and capacity to achieve FDA's public health mission.
The Office comprises the Office of Counterterrorism and Emerging Threats (OCET), the Office of Regulatory Science and Innovation (ORSI), the Office of Scientific Integrity (OSI), the Office of Scientific Professional Development (OSPD), the Office of Minority Health (OMH), the Office of Women's Health (OWH), and FDA's National Center for Toxicological Research (NCTR).
- Fosters development and use of innovative technologies to meet public health needs
- Supports scientific excellence and the professional development of FDA scientists in all areas (e.g., population/statistical, review, laboratory and manufacturing sciences), including through the Commissioner's Fellowship Program, continuing education, and scientific interactions with universities and others
- Provides strategic leadership and support for high quality, collaborative, scientific activities that advance regulatory science and address important public health issues concerning FDA regulated products, including their evaluation, quality, safety and effectiveness
- Provides support and guidance for the NCTR to serve as a national FDA resource for mission driven regulatory science
- Provides cross-agency scientific coordination (e.g., for emerging technologies, scientific issues involving multiple agency components, standards coordination, the FDA Science Board, and science communication)
- Supports scientific outreach, training, and collaboration, including research, development and Critical Path activities that engage other agencies, global regulatory partners, academia, innovators, and consumers
- Supports science and public health activities to effectively anticipate and respond to counter-terrorism and emerging deliberate and natural threats (e.g., chemical, biological, radiological and nuclear) to US and global health and security including through the Office of Counterterrorism and Emerging Threats
- Provides core scientific leadership and technical expertise, and ensuring agency capacity, for advanced bioinformatics activities needed to support FDA programs. Serve as an agency and government resource for excellence, methods development, outreach and partnerships in advanced bioinformatics science
- Leads agency efforts to protect and enhance scientific integrity, and, where substantive scientific differences of opinion arise and require review at the FDA level, addresses them through appropriate processes intended to protect both FDA’s mission and the integrity of its science.