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


CSPI Urges FDA To Follow “Intent” Of AER Law In Labeling Guidance

This article was originally published in The Tan Sheet

Executive Summary

The Center for Science in the Public Interest is urging FDA to require a statement on labels for OTC drugs and dietary supplements advising consumers to make any reports of any adverse reactions using telephone numbers or mailing addresses also printed on the packages

You may also be interested in...

AHPA Asks FDA To Allow Firms To Route AER Contact To Offices Outside U.S.

FDA's guidance on adverse event reporting for OTC drugs and dietary supplements should assure that firms operating outside the country can use U.S. addresses on their product labels but receive AER-related communication in their home countries, the American Herbal Products Association recommends

Adding Street Address To Product Label Likely In AER Guidance – CFSAN

FDA appears likely to include a street address recommendation in its guidance for dietary supplement and OTC product adverse event reporting, and a Center for Food Safety and Applied Nutrition executive assures industry the center is considering a guidance, not a rule

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

Related Content





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