CFSAN Addresses AER Duplication, NDI Definition In Developing Guidances
This article was originally published in The Tan Sheet
FDA is working on a method to avoid duplication when tracking adverse event reports, according to the director of CFSAN's Division of Dietary Supplement Programs
You may also be interested in...
Adverse Event Collection Expected To Be In Force By Christmas 2007
Firms that make, pack or distribute dietary supplements and over-the-counter drugs approved under monographs will likely have to be in compliance with a new adverse event reporting law by late December 2007
FDA Requiring GRAS-Level Safety Standards For NDI Submissions, Experts Say
FDA has gradually raised the safety standard for new dietary ingredients above the level intended by DSHEA, according to several experts
Walker leaves CFSAN
Susan Walker, MD, will depart CFSAN to head the Division of Dermatology & Dental Products in the Center for Drug Evaluation & Research's Office of New Drugs, FDA announces May 12. Walker joined the Center for Food Safety & Applied Nutrition in September 2003, where she served as director of the Division of Dietary Supplement Programs in the Office of Nutritional Products, Labeling, & Dietary Supplements. Among her responsibilities at CFSAN was the management of responses to structure/function claims and new dietary ingredient notifications. In May 2005, Walker received an HHS Secretary's Award for Distinguished Service for "outstanding performance" in development of the final rule prohibiting the sale of supplements containing ephedrine alkaloids, the agency notes...