Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
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)
You may also be interested in...
Regulatory News In Brief
FDA issues final guidances on institutional review board responsibilities and adverse event reporting during a flu pandemic. Request for Risk Communication Advisory Committee nominations. More regulatory news.
Smoking Cessation Claims For E-Cigarettes Draw FDA Warnings
FDA set ground rules for regulating electronic cigarettes in Sept. 8 warning letters to five firms about unapproved smoking cessation claims and in a separate summary letter to an industry trade group
Smoking Cessation Claims For E-Cigarettes Draw FDA Warnings
FDA set ground rules for regulating electronic cigarettes in Sept. 8 warning letters to five firms about unapproved smoking cessation claims and in a separate summary letter to an industry trade group