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FDA-TRACK OC Office of the Chief Scientist Dashboard

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Note: Information is as of November 30, 2016. The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.

STRATEGIC PRIORITY I: Support mission critical targeted research and raise the profile of regulatory science

Objective 1 - Assist FDA's Science Board in producing a report entitled, "FDA Science Looking Forward" that highlights the current strengths of regulatory science at FDA and evaluates the Agency's readiness and needs related to regulatory science

Lead: Office of the Chief Scientist (OCS)

Measures are under development and will be available once finalized.

Objective 2 - Support highly meritorious projects, and scientific coordination and collaboration, in priority areas, including behavioral science, and focused on work that is not normally supported by the Agency’s individual program areas, through diverse approaches including:

a)  Fund at least one new Center of Excellence in Regulatory Science (CERSI), selected by peer review from a national solicitation

Lead: ORSI

I. Centers of Excellence in Regulatory Science and Innovation (CERSI) Established in 2014

b) Execute the new FDA Broad Agency announcement (BAA) which solicits and funds meritorious regulatory science proposals from non-federal scientists

Lead: ORSI

II. FDA Broad Agency Announcement (BAA) or Program for Extramural Regulatory Science and Innovation (PERSI)

c) Support FDA intramural scientific excellence and collaboration through recognition of outstanding scientists (e.g., FDA Scientific Achievement Awards) and by providing intramural seed funding (e.g., Chief Scientist’s Challenge Grant and ORSI, OWH, OMH, OCET) in specific priority areas for work not otherwise supported by FDA programs, including for collaborations across organization boundaries (e.g. nanotechnology CORES program) 

Lead: ORSI

III. Office of the Chief Scientist Intramural Research Grants

Objective 3 - Develop a research roadmap for women’s health to identify knowledge gaps, address emerging women’s health issues, and support the Centers’ regulatory question and issues around women’s health and sex differences in the response to medical products

Lead: Office of Women's Health (OWH)

Measures are under development and will be available once finalized.

Objective 4 - Enhance the gathering and evaluation of subpopulation data and support targeted research to reduce health disparities by supporting ORISE fellows in FDA Centers, intramural research grants (OWH) and through the CERSI Minority Health projects.

Lead: Office of Minority Health (OMH)

Measures are under development and will be available once finalized.

Objective 5 - Support science and new tools to enhance bi-directional communication with diverse populations including through use of social media to detect adverse events and through enhancing FDA’s strategies and capacity to provide audience appropriate and clear health and product information

Lead: OWH, OMH

IV. Time to Take Care Outreach Program - FY17 Activities

V. Language Access Program

VI. Diversity in Clinical Trials

Objective 6 - The OWH Intramural Research Program aims to facilitate FDA regulatory decision-making by supporting research and workshops that address: (1) health conditions and diseases that solely or disproportionately affect women; (2) the identification and understanding of sex differences related to the safety or efficacy of FDA-regulated products; and (3) emerging women’s health issues.

Lead: OWH

V. OWH Intramural Research Program

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STRATEGIC PRIORITY II: Ensure that our nation is prepared for threats of emerging infectious diseases, pandemics and terrorism

Objective 1 - Increase research collaboration in MCM science both internally and externally and continue to support and enhance strong external scientific relationships with HHS sister agencies, DOD agencies, and laboratories including through the NICBR and DARPA

Measures are under development and will be available once finalized.

Objective 2 - Develop, characterize, and qualify animal models for MCM development to demonstrate a response to the countermeasure that will be predictive for humans, including the ability to extrapolate pharmacokinetic/pharmacodynamic (PK/PD) data from animals to humans to determine appropriate dosing in humans

Center for Drug Evaluation and Research (CDER)

I. Animal Models of Pregnancy to Address Medical Countermeasures (MCM) for Influenza and Chemical, Biological, Radiological and Nuclear Threats in the 'At-Risk' Population of Pregnant Women

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STRATEGIC PRIORITY III: Support an environment of scientific excellence, learning and integrity

Objective 1 - Help recruit and train a next generation of scientists, including through the support of the Commissioner’s and other Fellowship programs and by increasing the access and profile of FDA’s Fellowship and Student programs on the Internet

Lead: Office of Scientific Professional Development (OSPD)

I. Commissioner's Fellowship Program Measures

A. Train and hire outstanding healthcare professionals, scientists, and engineers through completion of the Commissioner's Fellowship Program, a two year mentorship combining rigorous graduate-level coursework with the development of a regulatory science research project

1. Percentage of Commissioner's Fellows who graduated and who were retained at FDA

2. Number of projects completed, peer reviewed presentations made, and peer reviewed manuscripts published by Commissioner's Fellows

II. Commissioner's Fellowship Program

Objective 2 - Support an environment of excellence and continuous learning for FDA scientists by enhancing opportunities for continuing education and professional development and other training opportunities through expanded activities with the CERSI’s and collaborations with other academic and governmental partners (OSPD), and with scientific training that addresses population based differences in health outcomes and health disparities, e.g., NIH and pharmacy school courses (OMH, OWH). Raise the profile of and access to scientific training activities for FDA staff and stakeholders through an enhanced internet training presence and access to new offerings, including the comprehensive FDA 101 course.

Lead: OSPD, OWH

III. Training and Continuing Education Measures

A. Enhance continuing education and scientific training opportunities for FDA working with subject matter experts and collaborating with external organizations

1. Number of FDA sponsored regulatory science training events completed, participants who completed training events, and Continuing Education (CE) credits awarded

2. Number of FDA regulatory science training collaboration events completed, participants who completed training events, and Continuing Education (CE) credits awarded

Other Core Operations

Lead: Office of Health Informatics (OHI)

I. Chillax

II. PrecisionFDA

III. OpenFDA

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