Access To Investigational Drugs Under FDA Proposed Rule Depends On Size Of Treatment Group
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency also details criteria for charging for investigational drugs in separate proposed rule.
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Access To Investigational Drugs Remains Challenge Despite New FDA Rules
FDA has widely publicized ways for patients to get access to investigational trial drugs outside of trials, but there are still many barriers that could hold up implementation in the real world
FDA Rules On INDs May Embolden More Patients To Ask For Trial Drugs
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