FDA CDER Develops Strategic Science and Research Agenda

Source: PharmaManufacturing.com

Jul 26, 2011

A U.S. Food and Drug Administration report from its Center for Drug Evaluation and Research (CDER), available today in the Federal Register, identifies the current regulatory science needs that will guide CDER’s strategic planning of internal research initiatives and contributions to the development of agency regulatory science efforts. 

“Communicating our science and research needs represents an important step in stimulating research and fostering collaborations with our external partners,” said CDER director Janet Woodcock, M.D. “We look forward to hearing from and working with our stakeholders.”

The report, “Identifying CDER’s Science and Research Needs Report,” identifies the following categories of science and research needs:

    * Improve access to post-market data sources and explore feasibility of their use in different types of analyses
    * Improve risk assessment and management strategies to reinforce the safe use of drugs
    * Evaluate the effectiveness and impact of different types of regulatory communications to the public and other stakeholders
    * Evaluate the link among product quality attributes, manufacturing processes and product performance
    * Develop and improve predictive models of safety and efficacy in humans
    * Improve clinical trial design, analysis and conduct
    * Enhance individualization of patient treatment

This docket will be open for review and public comment for 60 days after publication in the Federal Register notice.
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