The FDA Just Blew Up 60 Years of Drug Approval — With an AI Data Feed
For sixty years, getting a drug approved in America has followed the same grinding playbook: run a trial, collect data, package millions of pages of submissions, send it to the FDA, and wait. The average journey from Phase 1 to market takes 10 to 12 years. Nearly half of that, according to FDA Commissioner Marty Makary, is “dead time” — paperwork, administrative lag, and data sitting in limbo. On Tuesday, the FDA said it’s done with dead time. ...