By: Peter Marks, M.D., Ph.D., Jeffrey Shuren, M.D., J.D., and Janet Woodcock, M.D.
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.
FDARA reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) for the first time – allowing FDA to continue to collect medical product user fees through fiscal year 2022. The new law marks the culmination of two years of negotiations with industry and discussions with stakeholders. This is a compelling example of what can be achieved when FDA, industry, patients, Congress, and other stakeholders work together towards the same goal. Continue reading
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.
FDARA reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) for the first time – allowing FDA to continue to collect medical product user fees through fiscal year 2022. The new law marks the culmination of two years of negotiations with industry and discussions with stakeholders. This is a compelling example of what can be achieved when FDA, industry, patients, Congress, and other stakeholders work together towards the same goal. Continue reading
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