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Posted 11 May 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration's (FDA) biologics regulatory body, the Center for Biologics Research and Evaluation, has released its strategic regulatory plan for the upcoming five years.
The plan, "Strategic Plan for Regulatory Science and Research," was released 10 May 2012 and explores how the center plans to "provide the environment to facilitate the development of new biological products and evaluate them for safety and effectiveness."
CBER's plan outlines six core strategic goals it says will guide it through the next five years:
The Center notes regulating biologic products represents unique challenges as a result of the characteristics of living organisms, including their complexity, diversity of function, difficulty to manufacture, susceptibility to infection and potential long-term effects on the human body.
"These challenges require that CBER's regulatory science and research program supports CBER reviewer decisions so that they may be at the forefront of the underlying research fields that drive the development of these biologic products and the evolving technology designed to evaluate them," writes Karen Midthun, director of CBER.
Making sure these challenges are met requires the implementation of a "research management strategy that supports the overall goals of the regulatory science and research programs in order to ensure that research is relevant to our regulatory missions," says the report.
To accomplish these goals, CBER seeks to implement a four-pillared approach to its research management strategy, incorporating strategic planning and priority setting, the appropriate allocation of resources, a researcher-reviewer model and evaluation of its accomplishments.
CBER's said it plans to be "proactive, anticipating regulatory and public health issues while being responsive to emerging public health and regulatory issues."
Tags: Midthun, 2012-2016, Latest News, regulatory science, plan
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