Commentary on “Accounting for the Interim Safety Monitoring of an Adverse Event Upon Termination of a Clinical Trial”

摘要

After more than 100 deaths caused by the Elixir Sulfanilamide disaster,in 1938,the U.S.Congress passed the Federal Food,Drug,and Cosmetic Act(FDC Act) which for the first time in U.S.history required pharmaceutical companies to submit full reports of investigations regarding the safety of new drugs.