Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA may post 'untitled' letters online: FDA is considering posting on its Web site "untitled" letters issued to manufacturers. "In an era of enhanced enforcement and greater transparency, that's being discussed," according to Larry Spears, deputy director of regulatory affairs in CDRH's Office of Compliance. His comments came during FDAnews' recent Fourth Annual FDA Inspections Summit in Bethesda, Md. Currently, the agency only posts redacted warning letters online. "Untitled letters don't really meet the threshold of a warning letter," Spears said. "That means they're not significant enough that we would take a follow-up action necessarily with what we see, but there are problems that need to be identified to the company because we've looked at the evidence and believe there are problems. So we want to identify those in an untitled letter.