June 21, 2006
FDA eyes tougher drug trial rules: WSJ
The FDA is looking to re-evaluate its regulation of clinical trials, with plans including a proposal to force drugmakers to inform the agency if they believe a researcher has committed fraud during a study, The Wall Street Journal reported today.
FDA deputy commissioner Janet Woodcock was expected to discuss the initiative today during the Drug Information Association’s annual meeting in Philadelphia.
Among the actions, the FDA is expected to launch an effort to standardize forms used to collect information in studies, adjust rules on how patients access experimental treatments and clarify which adverse events in trials have been reported to review boards that monitor studies, a report on the newspaper’s Web site said.