New ALS drugs should still use randomized, placebo-controlled trials to show efficacy, the US Food and Drug Administration says, but the agency clarified that it is not necessarily married to the traditional study design for the products.
US FDA Reassures ALS Patients In Final Development Guidance
ALS advocates succeed in getting the FDA to soften its stance on use of randomized, placebo-controlled trials for drug development; final guidance also encourages patient-reported outcomes.
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