FDA Approval Pathways 101

Key Resources

(listed chronologically, beginning with the most )

“FDA 101: An Overview of FDA’s Regulatory Review and Research Activities.” U.S. Food and Drug Administration. December 17, 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.

“COVID-19 lesson: New FDA chief, when chosen, must crack down on clinical trial transparency.” Rabinovitsj, J., Rohr, C., Ramachandran, R. The Baltimore Sun. May 13, 2021. Available here.

“Drug Approval Pathways.” American Academy of Neurology. December 2020. Available here.

“Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review.” U.S. Food and Drug Administration. February 23, 2018. Available here.

Additional Resources

(listed chronologically, beginning with the most recent)

“Senate HELP Committee Advances User Fee Reauthorization.” Mahr, K., Owermohle, S. Politico. June 15, 2022. Available here.

“About the Food and Drug Administration (FDA) Sentinel Initiative.” U.S. Food and Drug Administration. 2022. Available here.

“The Basics and the Process of Drug Approval.” DiProspero, D., CRB Group. 2022. Available here.

“Lessons From COVID-19: How Policymakers Should Reform the Regulation of Clinical Testing.” Sluzala, Z., Haislmaier, E. The Heritage Foundation. March 28, 2022. Available here.

“Understanding the History and Use of the Accelerated Approval Pathway.” Stengel, K., Zaleski, Z., West (Olsen), M., et al. Avalere. January 4, 2022. Available here.

“FDA’s Policy Changes for COVID-19 At-Home Diagnostics—Implications for Addressing Other Infectious Diseases and Future Pandemics.” Gottlieb, S. JAMA Health Forum. December 23, 2021. Available here.

“Enhancing Clinical Trial Diversity.” Younossi, A., Sanhai, W., Shah, S., et al. Deloitte. November 11, 2021. Available here.

“Accelerated Approval: Bringing Patients Access to Needed Medicines.” PhRMA. October 6, 2021. Available

“Reducing Medicaid Prescription Drug Costs While Maintaining Beneficiary Access: MACPAC Recommendations for Accelerated-Approval Drugs.” Martin, K. The Commonwealth Fund. August 18, 2021. Available here.

“Accelerated Approval—An Unexpected Pathway To Value-Based Pricing?” Lederer, N., Dusetzina, S. Health Affairs. August 18, 2021. Available here.

“ICER Publishes White Paper Evaluating Policy Options to Strengthen FDA’s Accelerated Approval Pathway for Prescription Drugs.” Kaltenboeck, A., Mehlman, A., Pearson, S. Institute for Clinical and Economic Review. April 26, 2021. Available here.

“Reducing Spending on Prescription Drugs with Limited Clinical Evidence.” Park, E. The Commonwealth Fund. April 8, 2021. Available here.

“Racial Diversity within COVID-19 Vaccine Clinical Trials: Key Questions and Answers.” Artiga, S., Kates, J., Michaud, J., et al. Kaiser Family Foundation. January 26, 2021. Available here.

“KHN launches “Pre$cription for Power,” a groundbreaking database to expose Big Pharma’s ties to patient groups.” Kopp, E., Lupkin, S., Lucas, E. Kaiser Health News. April 6, 2018. Available here.

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