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FDA launches pain drug partnership

The US Food and Drug Administration has entered into a partnership with the University of Rochester to develop an initiative for analgaesic drugs

The US Food and Drug Administration (FDA) has entered into a partnership with the University of Rochester to develop an initiative aimed at streamlining the discovery and development process for analgaesic drugs.

Called the Analgaesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) Initiative, the effort is intended to address the information gaps that currently hinder development of drugs for pain. Objectives of the partnership include coordinating scientific workshops with experts in the fields of anesthesia and analgaesia and conducting "in-depth and wide-ranging data analyses of analgaesic clinical trial data to determine the effects of specific research designs and analysis methods."

The multi-year, multi-phased initiative will work to establish relationships with key expert stakeholders, industry, professional organisations, academia and government agencies, the FDA said.

Information coming out of the initiative, including study results and best practices, will be made public on the FDA's website as it becomes available.

The new partnership has been formed in conjunction with the FDA's wide-ranging Initiative for the Advancement of Regulatory Science, which was launched last month in an effort to advance the field of regulatory science, which the FDA defines as "the science of developing new tools and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products."

The University of Rochester is a private institution in Rochester, New York.  Its medical center has a $232m research budget and employs thousands of scientists. Robert H Dworkin, professor of anesthesiology, neurology, oncology, and psychiatry at the medical centre, will head up the partnership with the FDA. Dworkin is a highly regarded researcher with a focus on clinical trial methodology for analgaesics who serves on the editorial boards of several prestigious journals, including Pain.

2nd November 2010


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