Federal · Title 21 — Food and Drugs

21 U.S.C. § 399a: Office of the Chief Scientist

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The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Office. oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food and Drug Administration; track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug Administration; develop and advocate for a budget to support intramural research; develop a peer review process by which intramural research can be evaluated; representatives of each of the centers and the science-based offices within the Office of the Commissioner; and experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.

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