New FDA/NIH Program on Regulatory Science

Progress happens when problems or opportunities are recognized and resources are marshaled to address them. No one project is likely to fully address any one overarching problem or opportunity, but individual efforts can help move things in the right direction. It's in this spirit that we recognize a new program announced recently by U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg and U.S. National Institutes of Health (NIH) Director Francis Collins.

The new program, entitled "Advancing Regulatory Science through Novel Research and Science-Based Technologies," will make $6.75 Million available in grants for "new methods, models, or technologies that will inform the scientific and regulatory community about better approaches to evaluating safety and efficacy in medical product development" (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201706.htm). This program is intended to help tackle the perceived mismatch between biomedical science, which can lead to potential new therapies, and regulatory science, which evaluates the safety and efficacy of these new therapies (drugs, vaccines, medical devices, etc.). Commissioner Hamburg has likened this mismatch to a rower who has one strong arm (biomedical science) and one weak arm (regulatory science).

With the FDA reportedly on the verge of joining the Tox21 program, and with this new joint program with the NIH, the FDA is poised to become a major player in ushering in "21^st Century Toxicology."

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