CDER, CBER, and CDRH Directors Praise FDARA Reauthorization

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The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.

In an FDA Voiceblog post, dated August 21, 2017, Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research; Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health; and Janet Woodcock, MD, director of the Center for Drug Evaluation and Research expressed their appreciation for Congress’ passage of the FDA Reauthorization Act of 2017 (FDARA). President Trump signed FDARA into law on Friday, August 18, 2017.

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). These acts and amendments allow FDA to collect user fees from industry stakeholders. These fees are then used to fund a variety of agency programs. 

“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,” the directors stated in the blog post.

According to the directors, the user fees will help the agency to advance drug development, facilitate the timely approval of drugs and biologics, leverage real-world health data, strengthen partnerships with patients, and streamline reviews.


“As a whole, the reauthorization of PDUFA, MDUFA, GDUFA, and BsUFA will allow FDA to improve upon the demonstrated successes of these programs, and in so doing, further benefit patients and affirm our nation’s standing as a global leader in biomedical innovation,” the directors said.

Source: FDA