NIH, FDA dole out $9 million to advance “regulatory science”

FDA, NIH logos

The National Institutes of Health and the Food & Drug Administration will dole out $9.4 million over three years to support a quartet of research projects in so-called "regulatory science."

The program is aimed at improving data for scientists and regulatory reviewers on medical device safety and at improving the "evaluation and availability of new medical products to the community," according to a press release.

The FDA will put about $950,000 toward the grants, according to the release. It’s part of a joint effort announced early this year designed to speed innovative medical technologies to market. When the cooperative effort was announced, the agencies said their total kitty was about $6.75 million over three years.

Regulatory science is the "development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality,” according to the February announcement of the program.

Here are the details on the recipients of the four grants:

  • Dr. Donald Ingber of Harvard University Medical School in Boston — “Heart-Lung Micromachine for Safety and Efficacy Testing”
  • Dr. William Barsan, Donald Berry and Roger Lewis of the University of Michigan in Ann Arbor — “Accelerating Drug and Device Evaluation through Innovative Clinical Trial Design”
  • Daniel Cerven and George DeGeorge of MB Research Laboratories Inc. in Spinnerstown, Pa. — “Replacement Ocular Battery (ROBatt)”
  • Dennis Hourcade of Washington University in St. Louis — “Characterization/Bioinformatics-modeling of Nanoparticle: Complement Interactions”

“These four projects were chosen among many applications because they were the most meritorious proposals for addressing high-priority areas in cutting-edge biomedical research and regulatory science. This partnership marks the beginning of our work with FDA to use new scientific and technological tools to aid/enhance the review of new drugs and devices. It is one facet of our shared commitment to speed the delivery of new medical products to patients,” NIH director Dr. Francis Collins said in prepared remarks.

“These projects show the potential breadth of opportunity that comes from advancing regulatory science. The results are likely to have broad application to researchers across scientific disciplines and will result in better-informed regulatory decision-making and faster drug development and approval processes,” added FDA commissioner Dr. Margaret Hamburg.

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