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Published on 1 February 2007

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Strengthening the US drug safety system

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In response to recommendations made by the US Institute of Medicine (IoM), the FDA has outlined a number of initiatives to make drug safety programmes as best as possible.

The report by the IoM claimed that a “perception of crisis” is harming the credibility of both the FDA and the pharmaceutical industry, and that they are failing to communicate drug safety concerns to the public in a timely, effective manner.

The report also emphasised that chronic underfunding, a lack of clear regulatory authority, a significant tail-off of FDA resources devoted to new products once they are marketed an inadequate post-approval data are harming the agency’s ability to monitor newly-marketed drugs.

The FDA said that concrete steps should be taken in strengthening the science that supports the FDA’s medical product safety system at every stage of product life cycle, from premarket testing and development to postmarket surveillance and risk management. Measures will also be implemented to improve communication and information flow among all stakeholders engaged in promoting the safe use of medical products and to improve operations and management to ensure implementation of the review, analysis, consultation and communication processes needed to strengthen the US drug safety system.



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