FDARA: making a difference for industry and patients

FDA

21 August 2017 - For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure the safety and effectiveness of medical products that American patients depend upon.

Since passage of the first medical product user fee act in 1992, the user fee laws and corresponding performance goals and program enhancements have helped evolve the drug and device review process in the United States allowing patients access to new and innovative treatments as quickly as possible without compromising the Agency’s high standards.

As directors of FDA’s three medical product centers, we want to applaud the U.S. Congress for passing the FDA Reauthorization Act of 2017 (FDARA), which President Trump signed into law on Friday.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation