FDA maintains Covid flexibilities for IRB review of expanded access drugs for individuals
The FDA indicated that it will maintain some pandemic-era flexibilities in institutional review board (IRB) assessments of expanded access drugs for individual patients in immediately-in-effect guidance published Friday.
The FDA explains in the eight-page guidance that expanded access drugs refers to investigational drugs that serve the main purpose of treating, diagnosing or monitoring a patient’s disease as opposed to gleaning information about the drug, which is generally the main purpose of a clinical trial.
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