regulatory and translational science, through the expertise available in FDA and NIH for efficiently and effectively guiding biomedical discoveries into safe therapies for the public. It will be led by a newly established Joint FDA–NIH Leadership Council,1 which will be charged with including regulatory considerations in biomedical research and vice versa. As a part of the Initiative, FDA and NIH issued a joint Request for Applications making available $6.75 million dollars for work in regulatory science over the course of three years.

“We now have a special opportunity—and responsibility—to harness advances in science and technology to support our efforts. We are working in collaboration with the best minds and research institutions available, so that we can better develop and utilize new tools, standards and approaches needed to properly assess the safety, effectiveness and quality of products currently in development or already on the market,” said Hamburg at the announcement of the initiative (NIH, 2010).


Goodman stated that FDA must proceed with the development of regulatory science regardless of external barriers. He outlined the following key implementation steps for first creating an internal support system for a regulatory science infrastructure at the agency:

  • Leadership to strengthen and support science and promote innovation at FDA—Both the Commissioner’s Office and leadership at FDA centers are supportive of promoting science and innovation. There is interest across the agency in multicenter working groups, scientific guidance, and sharing of resources. Goodman also announced the creation a new Office of Science and Innovation within the Office of the Chief Scientist to coordinate such efforts.

  • Excellence in professional development—Professional development is essential to a scientific career and needs to be built in at the agency level. Goodman acknowledged that some FDA staff are unable to attend professional meetings because of either funding or time constraints. Given the success of staff colleges at each FDA center, Goodman encouraged the development of training programs at NIH and local universities, as well as online programs for staff.

  • Recruitment and retention of outstanding scientists—Building regulatory science at FDA will require that the agency recruit and

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