Regulatory changes key: Hamburg

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FDA commissioner Margaret Hamburg says it is important for the nation to strengthen its commitment to regulatory science so that it becomes a robust and respected discipline in the broader scientific enterprise. Her comments were made during an interview she gave to at the Cleveland Clinic healthcare summit in October.

Hamburg said that changes in the way regulatory science is viewed are “the key to ensuring that recent scientific discoveries that hold such promise are actually translated into new therapies and treatments.”

Asked what can be done to restore public trust in FDA, Hamburg said that increasing transparency will help break down the perception of FDA as a bureaucratic “black box.” She said it also needs to be recognized that we live in a world in which there will always be risks and crises, but there is much more than can be done to prevent such problems. “During a crisis we have to not be afraid to communicate rather than circle the wagons, which has happened before,” she said. “We have been taking a very clear-eyed look at past problems to learn from these mistakes.”

 On drug development, Hamburg said FDA is looking at ways to streamline the regulatory process and make it more effective. “There are real opportunities to apply emerging science to the regulatory process,” she said.

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