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FDA report recognises need for improvement

A US Food and Drug Administration report has highlighted seven areas where the agency's regulatory efforts are in need of development or improvement

A report from the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has identified seven research and science needs that will help develop its regulatory science efforts.

The Identifying CDER's Science and Research Needs report recognises the need to develop, evaluate and/or improve: data and methods for the analyses of postmarket data; risk management strategies; scientific approaches to regulatory communications; product quality and performance; predictive models; design, analysis, and monitoring of clinical trials; and individualisation of patient treatment.

The report states: 'The seven categories constitute clearly identified major themes, but do not encompass every articulated need. As presented in this document, the needs have not been prioritised. The results are intended to serve as a framework for further steps to identify gaps and prioritise needs within the categories.'

The FDA has the report available to download.

26th July 2011

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