FDA Issues Statement on Post-Trial Treatment via Expanded Access
FDA issues statement of transparency on the use of Expanded Access (EA) Programs as the mechanism for post-trial access. "Once a trial is complete, EA is generally available when clinical trial results show that the drug is effective in the studies population. However, sometimes drugs that have not shown benefit across the overall study population may still be providing benefit for individual patients. EA may have a role in allowing patients to have continued access to the drug."