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Monitoring Drug Safety

FDA has said that that it will promote a culture of openness and enhanced// oversight within the agency. As part of this vision, FDA will create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues, and will provide emerging information to health providers and patients about the risks and benefits of medicines.

Specific proposals for immediate and fundamental steps to improve the way the FDA manages drug safety information was announced. These proposals would focus on making FDA's review and decision-making processes more independent and transparent.

FDA will enhance the independence of internal deliberations and decisions regarding risk/ benefit analyses and consumer safety by creating an independent Drug Safety Oversight Board (DSB). The DSB will oversee the management of important drug safety issues within the Center for Drug Evaluation and Research (CDER). The board also will consult with other medical experts and representatives of patient and consumer groups.

FDA will also increase the transparency of the Agency's decision-making process by establishing new and expanding existing communication channels to provide targeted drug safety information to the public. The increased openness will enable patients and their healthcare professionals to make better-informed decisions about individual treatment options.

As FDA develops these communications formats, the Agency will be soliciting public input on how FDA should manage potential concerns associated with disseminating emerging information prior to regulatory action. In addition, FDA will actively seek feedback from healthcare professionals and patients on how best to make this information available to them.

A cornerstone of all information collection, evaluation, and communication proposals in an age of increasing electronic health information must be a strict adherence to maintaining patient privacy. FDA is commi tted to maintaining this patient privacy.


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