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)