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Confirmatory Trials of Accelerated Approval Drugs — Will Imposing Fines Reduce Delays?
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Confirmatory Trials of Accelerated Approval Drugs — Will Imposing Fines Reduce Delays?
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Journal Article
Confirmatory Trials of Accelerated Approval Drugs — Will Imposing Fines Reduce Delays?
2024
Overview
Confirmatory Trials of Accelerated Approval DrugsIn order to ensure timely testing of drugs that have been granted accelerated approval, the FDA can impose civil monetary penalties on dilatory manufacturers — but has never done so.
Publisher
Massachusetts Medical Society
Subject
/ Cancer
/ Clinical Trials as Topic - economics
/ Clinical Trials as Topic - legislation & jurisprudence
/ Devices
/ Drug Approval - legislation & jurisprudence
/ Drug Industry - legislation & jurisprudence
/ Drugs
/ Humans
/ Law
/ Medicare
/ Patients
/ Reforms
/ United States Food and Drug Administration - legislation & jurisprudence
