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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.

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Regulatory News In Brief

FDA fundamentals: Agency launches its 1FDA Basics Web site Jan. 12 as the first phase of its transparency initiative. The site attempts to explain FDA operations, decision-making and product review processes in consumer-friendly language with question-and-answer sections and video conversations with agency personnel. It also will feature live online sessions with senior officials answering questions on various topics. FDA Basics includes a page for each FDA product section; the device page discusses the difference between the terms "clears" and "approves," and what recalls mean for implanted devices. The FDA Transparency Task Force plans to make recommendations to the commissioner for general transparency policy changes by the end of February. In the final phase of the initiative, the task force will make recommendations to regulated industries, probably by mid-year (2"The Gray Sheet" Nov. 16, 2009)

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