Sunday, October 31, 2010

Regulatory Science

Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products including drug, biological products, medical device and more. On February 24, 2010, FDA along with NIH launched its Advancing Regulatory Science Initiative (ARS) aim to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients.

On October 6, 2010, the U.S. Food and Drug Administration unveiled an overview of initiatives to advance regulatory science and help the agency assess the "safety, efficacy, quality and performance of FDA-regulated products." And published its white paper  Advancing Regulatory Science for Public Health - A Framework for FDA's Regulatory Science Initiative” The white paper outlines the agency's effort to modernize its tools and processes for evaluating everything from nanotechnology to medical devices to tobacco products.

In companion to the release of the white paper, FDA commissioner, Dr Hamburg gave a speech to the National Press Club in Washington, DC

In the white paper, the section I “Accelerating the Delivery of New Medical Treatments to Patients” has specific meaning to statisticians. “Adaptive design” was not specifically mentioned in the white paper, however, any approach or methodology in clinical trial design that can expedite the drug development process should be encouraged. The personalized medicine should also be encouraged.

Even though the regulatory science or regulatory affairs is critical in drug development field, the professionals working in the field are very diversified and come from variety of different backgrounds. Perhaps, you can only learn the regulatory science through the experience and on-job training. However, I do notice that USC has a graduate program in regulatory science. Considering that FDA is increasing its investment in regulatory science and the regulatory laws are getting more and more complicated, the graduates from this program should not have any difficulty in finding a job.

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