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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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Office of the Chief Scientist

Overview

 

The Office of the Chief Scientist (OCS) provides strategic leadership, coordination, and research expertise to support scientific excellence, innovation, and capacity to achieve the FDA public health mission. 

  • Cross-Cutting Functions: OCS leads FDA-wide scientific initiatives and programs to advance FDA science across all FDA-regulated product areas.
  • Research and Testing: OCS advances public health protection through state-of-the-art science and analysis in its network of laboratories across the country.
  • Regulation and Coordination: OCS oversees the regulation of cosmetic products and certification of color additives for cosmetics, food, drugs, and devices.

OCS Organization Chart

OCS High Level Organization Chart

Under the FDA reorganization, effective October 1, 2024, OCS has expanded its capabilities as part of an agency-wide effort to strengthen and advance public health protection. To learn more about the reorganization, please visit this page. For a pdf copy of the organization chart and descriptions of OCS's components, click here.

Office of the Chief Scientist Components

Cross-Cutting Functions

Provides strategic leadership, coordination, and support for innovation in FDA regulatory science and preparedness research programs to advance FDA’s ability to protect and promote public health. For more information about ORES, click here.

Supports innovative professional development and training activities targeted at FDA’s scientists and stakeholders. For more information about OSPD, click here.

Develops and implements policies to promote and protect integrity in scientific decision-making throughout FDA. For more information about OSI, click here.

Ensures that FDA laboratories and workplaces are operated in a safe and secure manner. For more information about OOSH, click here.

Research and Testing

Plans and conducts scientific research related to product safety and toxicology in support of FDA regulatory needs and decision-making.  For more information about NCTR, click here.

Conducts laboratory analytical testing to assess sample compliance with FDA laws and regulations, identify trends, and inform regulatory decision-making for pharmaceuticals, tobacco, nanotechnology, and cosmetics. For more information about OARL, click here.

Coordinates with OCS testing laboratories and FDA Centers and Offices on laboratory science activities to facilitate a cohesive approach to public health protection through cross-collaboration. For more information about OSLA, click here.

Plans and conducts laboratory testing within the National Forensic Chemistry Center and the Winchester Engineering and Analytical Center in support of FDA’s regulatory and public health mission. For more information about OSLES, click here.

Regulation and Coordination

Directs and coordinates the cosmetics and color additive programs, including efforts under the Modernization of Cosmetics Regulation Act of 2022. For more information about OCAC, click here.

OCS Immediate Office Staffs

Ensures the smooth conduct of FDA’s advisory committees, which provide independent scientific advice and recommendations to FDA. For more information about advisory committees, click here.

Implements Federal Technology Transfer Act of 1986 and related legislation through programs that support FDA collaborative research with external partners and enable the transfer of FDA’s inventions into public health solutions. For more information about TTP, click here. 

Provides guidance and leadership on administrative management policies, guidelines, issues, and concerns that impact office programs and initiatives.

Manages and assesses OCS information technology (IT) portfolio and IT needs across OCS program areas, in collaboration with OCS subcomponents.

OCS Initiatives

FDA is advancing alternative methods for regulatory use. Alternative Methods have the potential to provide more timely and more predictive information to assess certain aspects of FDA-regulated products while also replacing, reducing and/or refining animal testing (the 3Rs).

The goal of the CERSIs is to advance regulatory science through collaborative interactions with FDA scientific experts and funding offices. 

Since 2012, FDA has been soliciting proposals through a specialized contract mechanism known as FDA's BAA, which makes it possible for us to solicit innovative ideas and approaches to developing and evaluating FDA-regulated products by tapping into external knowledge and infrastructure in areas where FDA has limited expertise or capacities.

The FDA Grand Rounds is an educational presentation that is webcast monthly to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health.

FDA's Science Forum offers an exciting opportunity for the public to view the unique scientific research and collaborative efforts of FDA’s scientists, who speak about the critical contributions that FDA's regulatory science makes to product quality and safety to the public, industry, academia, patient advocates, sister agencies, and current and potential collaborators.



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