BOX 3-5

NIH Request for Applications on Advancing Regulatory Science Through Novel Research and Science-Based Technologies (February 24, 2010)

Purpose. This regulatory science initiative encourages grant applications that propose to study the applicability of novel technologies and approaches to the development and regulatory review of medical products (including drugs, biologics, and devices).

Research Scope. Applications should fall within five broad categories:

  1. New tools and methodologies for assessing medical product safety and efficacy (including drugs, biologics, and devices and point of care diagnostics);

  2. Novel information technologies and statistical models that can improve product evaluation and inform regulatory decisions;

  3. Strategic design of research in “omics” and systems biology to better inform regulatory decision-making and support product development;

  4. Research on rare diseases/small sample size populations; and

  5. Novel approaches addressing optimal study designs for clinical trials.

This initiative will contribute to the overall goals of improving regulatory science by supporting research in at least one area of medical product development ranging from in vitro and in vivo product characterization and evaluation through clinical studies and to a manufactured, approved product.

SOURCE: NIH, 2010b.

Center for Drug Evaluation and Research

According to the 2007 Science Board report, in 2006 CDER regulated drugs accounting for $275 billion in pharmaceutical sales, and it also regulated some 5,000 domestic and foreign manufacturers of these pharmaceuticals. For FY 2006, the report showed total funding of just under $508 million of which about $298 million (58 percent) came from congressional appropriations with the rest provided by user fees. For FY 2009, total funding for the CDER was just over $656 million, of which about $300 million (45 percent) came from appropriations. In addition to resources, CDER and other FDA centers faced significant personnel challenges in recruitment, retention, performance, and professional development. The Science Board report noted the absence of good measures of performance in areas such as review of new product applications for safety and efficacy and the fact that neither CDER nor other parts of the agency could obtain all the expertise they needed without the involvement of external scientists.

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