FDA simplifies compassionate use application
The FDA says a new form will make it easier for patients to get access to experimental medicines. The agency's commissioner for public health strategy, Peter Lurie, announced the new application on the FDA Voices Blog.
He noted that the new application builds on a compassionate use initiative the regulator authorized during the AIDS outbreak and that the form has continued to be an onerous one that required “26 separate types of information and seven attachments.” Lurie wrote that manufacturers used the same form when seeking approval for human clinical trials.
The new form is part of a larger overhaul: Lurie said the FDA redesigned its website to help explain the new process.