Please enable JavaScript.
Coggle requires JavaScript to display documents.
Are drugs approved through the FDA's expedited programs more likely to…
Are drugs approved through the FDA's expedited programs more likely to be flagged for post approval safety hazards compared to drugs approved through the regular evaluation?
-
Positives Impacts
Association of expedited review programs with post-marketing safety events of new drugs approved by the US food and drug administration between 2007 and 2017 (Bao Lui, 2022)
Drugs, Deception, Disclosure (Garreth McCrudden, 2023)
Impact of expedited programs in the United States, as foreign regulatory factors, on clinical development time in Japan (Gentaro Tajima, 2022)
Accelerated Approval Program (U.S Food and Drug Administration, 2024)
The risk we bear: The effects of review speed and industry user fees on new drug safety (Mary Olson, 2008)
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies (Craig Bleifer, 2025)
Risks and Concerns
Association of expedited review programs with post-marketing safety events of new drugs approved by the US food and drug administration between 2007 and 2017 (Bao Lui, 2022)
Era Of Faster FDA Drug Approval Has Also Seen Increased Black- Box Warnings And Market Withdrawals (Cassie Frank et al., 2014)
Strength of clinical evidence supporting the United States Food and Drug Administration Accelerated Approvals from 2015 to 2022 (Thomas Szucs et al., 2024)
Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study (Aaron Kesselheim, 2015)
The Hazards of Rapid Approval of New Drugs (Jennifer Martin, 2016)
Reevaluating the Accelerated Approval Process for Oncology Drugs (Wyndham Wilson, 2013)
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies (Craig Bleifer, 2025)
The risk we bear: The effects of review speed and industry user fees on new drug safety (Mary Olson, 2008)
-