Image

---

The Office of the Chief Scientist (OCS) supports the research foundation, science, and innovation that underpins FDA’s regulatory mission.  It does this through a broad framework that encompasses scientific collaborations, laboratory safety, the transfer of FDA inventions to the private sector, scientific integrity in FDA policy- and decision-making, the professional development of regulatory scientists, and its core research component--FDA’s National Center for Toxicological Research--which generates the vital data FDA requires for its regulatory decision-making and development of sound regulatory policy.  

Major Functions

• 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), 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 and development that engage other agencies, global regulatory partners, academia, innovators, and consumers
• Supports science and public health activities to effectively anticipate and respond to counterterrorism 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.

Related Links

• Meet the Acting Chief Scientist, Jacqueline A. O'Shaughnessy, PhD
• Advancing Alternative Methods at FDA
• FDA's Predictive Toxicology Roadmap
• Advancing Regulatory Science Broad Agency Announcement
• Centers of Excellence in Regulatory Science and Innovation (CERSI)
• FDA Grand Rounds. Register for CE Credit
• FDA Science Forum

---