Merrill Goozner reports that the FDA decided that it will no longer require that clinical trials submitted to the agency to get regulatory approval for a new drug adhere to the Helsinki Declaration.
Why should you care? Gooz says this "increases the likelihood that more trials will go abroad and that more of them will not even be registered with the FDA, which makes them all but impossible to monitor."
Huge issue. And, as Gooz points out, one not reported by many news organizations.
Posted by schwitz at May 11, 2008 09:36 AM | TrackBack