Key Resources
(listed chronologically, beginning with the most recent)
“PDUFA VII: Fiscal Years 2023-2027.” Food and Drug Administration. Available here.
“Hearing on “FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics.” House Committee on Energy and Commerce. February 3, 2022. Available here.
“FDA Human Medical Product User Fee Programs.” Bodie, A., Sarata, A. Congressional Research Service (CRS). September 27, 2021. Available here.
“The Prescription Drug User Fee Act (PDUFA VII).” Pharmaceutical Research and Manufacturers of America (PhRMA). August 2021. Available here.
“Health Policy Handbook, Chapter 4: U.S. Food and Drug Administration.” Rawal, P., Whitlock, R. Alliance for Health Policy. July 20, 2021. Available here.
“Drug Pricing and Pandemic Preparedness in the 2022 FDA User Fee Reauthorization Process.” Sharp, J., Kenyatta, K. The Commonwealth Fund. July 23, 2020. Available here.
Additional Resources
(listed chronologically, beginning with the most recent)
“Statement for the Record: FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics.” National Health Council. February 3, 2022. Available here.
“This Week at FDA: Congress to Begin Work on User Fee Reauthorization Next Week.” Mezher, M. Regulatory Affairs Professionals Society. January 28, 2022. Available here.
“5 Things to Watch in Health Care in 2022.” Scarborough, S. Arnold Ventures. January 19, 2022. Available here.
“Prescription Drug Policy, 2021 and 2022: The Year in Review, and the Year Ahead.” Sachs, R. Health Affairs. January 7, 2022. Available here.
“Medical Trial Diversity Ignored by FDA in Fee Plan, Groups Say.” Castronuovo, C. Bloomberg Law. December 14, 2021. Available here.
“Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments.” Federal Register. August 24, 2021. Available here.
“PDUFA VII is Critical for Future Biopharmaceutical Innovation and For Patients.” Moscicki, R. Pharmaceutical Research and Manufacturers of America (PhRMA). August 23, 2021. Available here.
“Prescription Drug User Fee Rates for Fiscal Year 2022.” Food and Drug Administration. August 16, 2021. Available here.
“The Prescription Drug User Fee Act Fact Sheet.” Pharmaceutical Research and Manufacturers of America (PhRMA). May 7, 2021. Available here.
“To Improve Competition in Generic Drug Markets, the FDA Should Discount User Fees for Small Players.” Dotzel, M., Frank, R., McGuire, T. et al. Health Affairs. April 15, 2021. Available here.
“FDA Drug Approval: Application Review Times Largely Reflect Agency Goals.” U.S. Government Accountability Office. April 6, 2020. Available here.
“FDA User Fees: How Do They Work?” Hawana, J. The National Law Review. January 28, 2020. Available here.
“Extending the User Fee Approach to Pharmaceuticals.” Cutler, D. JAMA Forum Archive. September 5, 2018. Available here.
“Prescription Drug User Fee Act (PDUFA): 2017 Reauthorization as PDUFA VI.” Dabrowska, A., Thaul, S. Congressional Research Service (CRS). March 16, 2018. Available here.
“The Prescription Drug User Fee Act: Cause for Concern?” Gabay, M. Hospital Pharmacy. February 12, 2018. Available here.
“Speed, Safety, and Industry Funding- From PDUFA I – PDUFA VI.” Darrow, J., Avorn, J., Kesselheim, A. The New England Journal of Medicine. December 7, 2017. Available here.
“The National Health Council and NORD Commend House Passage of FDA User Fee Reauthorization; Urge Senate to Follow Suit.” Sencen, L. NORD. July 12, 2017. Available here.
“PDUFA Legislation and Background.” Food and Drug Administration. Available here.
“Prescription Drug User Fee Amendments.” Food and Drug Administration. Available here.
“PDUFA.” Pharmaceutical Research and Manufacturers of America (PhRMA). Available here.
Resources for Last User Fee Process in 2017
“PDUFA VI: Fiscal Years 2018-2022.” Food and Drug Administration. Available here.
“Prescription Drug User Fee Act (PDUFA): 2017 Reauthorization as PDUFA VI.” Dabrowska, A., Thaul, S. Congressional Research Service. March 16, 2018. Available here.
“H.R. 2430- FDA Reauthorization Act of 2017.” Office of Congressman Greg Walden. August 18, 2017. Available here.
“Senate Passes FDA User Fee Reauthorization.” Kacik, A. Modern Healthcare. August 3, 2017. Available here.
“FDA User Fee Reauthorization Poised to Pass House of Representatives.” Sachs, R. Health Affairs. July 12, 2017. Available here.
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