Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

CFSAN Addresses AER Duplication, NDI Definition In Developing Guidances

This article was originally published in The Tan Sheet

Executive Summary

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...

Topics

UsernamePublicRestriction

Register

PS100491

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel