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FDA Unveils New Regulatory Science Strategy

NEW YORK (GenomeWeb News) –The US Food and Drug Administration has released a new plan to guide its regulatory science efforts, which will emphasize new efforts in personalized medicine and a wide range of areas to help the agency keep pace with an ever-changing biomedical and food safety environment.

Confronted with a public health portfolio that is "growing rapidly," the challenge of evaluating new technologies that are "quickly evolving," and the "realities of an expanding global economy," FDA said today that it has drafted a multi-pronged plan aimed at helping it "speed innovation, improve regulatory decision-making, and get products to people in need."

In its plan titled "Advancing Regulatory Science at FDA: A Strategic Plan," the agency has provided specific details for its Regulatory Science Initiative, which it outlined late last year, including plans in eight key areas. Included among these science priority areas are plans to stimulate new personalized medicine programs, implement new food safety systems, develop medical countermeasures to protect threats to global security, and to ensure its readiness to evaluate innovative emerging technologies.

“The breadth and scope of FDA’s regulatory oversight is extraordinary, touching the lives of every American, through the food they eat, the medicines they take, and the medical devices they use,” FDA Commissioner Margaret Hamburg said in a statement.

“As new discoveries yield increasingly complex products, this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy. It positions us to foster innovation through better science without compromising our high safety standard," Hamburg added.

FDA Chief Scientist Jesse Goodman added that new technologies provide opportunities to prevent diseases and to cure them and to grow the high-tech economy.

“This plan will help turn advances in science into products that benefit people, and help FDA assure that happens more quickly and safely," he said. "

The agency said to pursue this plan it expects to apply its knowledge base, labs, scientific computing, and expertise while collaborating with domestic and international partners in government and academia.

To pursue its personalized medicine strategy, FDA plans to collaborate with partners to catalyze development of personalized medicine, to advance the science and, to conduct of clinical trials. These include efforts to identify and qualify biomarkers for safety and efficacy of pharmacodynamic response, dose selection, disease severity, progression, and prognosis. The agency also will seek to develop new approaches for identifying biomarkers using 'omics, systems biology, and high throughput methods, and to monitor new developments in personalized medicine as they pertain to regulated medical products.

These studies also would involve developing new ways to reduce the variability of analytical methods for measuring biomarkers between platforms, developing requirements for demonstrating accuracy and reliability of biomarker devices. FDA also expects its strategy will involve continued participation in collaborative efforts, such as the MicroArray Quality Control Consortium, to evaluate the quality of validation strategies for emerging technologies.

In another priority area, FDA will take steps to improve its readiness to evaluate innovative emerging technologies and to "reliably assess" the safety and efficacy of products that stem from these new developments. Among other things, that effort will entail development of the necessary expertise and infrastructure, stimulating innovative products and assessment tools at the same time, and integrating new product quality and safety methods based on genomic, proteomic, metabolomic, and other 'omic technologies.

The other core priority areas FDA plans to focus on include efforts to: modernize toxicology in order to enhance product safety; support new approaches to improve product manufacturing and quality; harness diverse data through new information sciences; facilitate development of medical countermeasures to protect against threats to health and security; and strengthen social and behavioral sciences to help inform decision-making about regulated products.

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