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BioWorld - Wednesday, December 24, 2025
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Home » FDA lacks data to track postmarket, safety studies for expedited approval
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FDA lacks data to track postmarket, safety studies for expedited approval

Jan. 20, 2016
By Michael Fitzhugh
A lack of reliable, timely and easy-to-access data is restricting the FDA's ability to stay on top of safety issues that it commits to tracking following expedited approval of new drugs, according to a report published by the Government Accountability Office (GAO) that examined both fast track and breakthrough designations.
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