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Journal of Pharmaceutical Policy and Practice

Journal of Pharmaceutical Policy and Practice
A Comparison of the Food and Drug Administration’s and Health Canada’s Regulatory Decisions About Failed Confirmatory Trials for Oncology Drugs

This study compares decisions by the FDA and Health Canada about oncology drugs that were approved using either Accelerated Approval (FDA) or NOC/c (Health Canada), that failed confirmatory trials.

Journal of Pharmaceutical Policy and Practice
10/28/2021
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