Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

CRN priorities for CFSAN

This article was originally published in The Tan Sheet

Executive Summary

The Council for Responsible Nutrition asks FDA to prioritize providing guidance and conducting stakeholder meetings with industry on implementing the dietary supplement good manufacturing practices final rule, CRN says in comments submitted Aug. 29. Other CRN recommendations include FDA adding reviewers to expedite the Center for Food Safety and Applied Nutrition's evaluation of adverse event reports, which supplement and OTC firms will be required to submit beginning in December under the AER law Congress enacted in 2006, and to amend the MedWatch form to include space to indicate whether consumers say they will allow their physicians to speak with firms' medical representatives (1"The Tan Sheet" Aug. 20, 2007, p. 13)...

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

California Court’s Inaction On TiO2 Prop 65 First Amendment Case Breeds New Lawsuits

The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.

Kenvue Breaks Ground On New Headquarters, Appoints Chief Corporate Affairs Officer

Firm hosts groundbreaking for 290,000 square-foot global headquarters it’s having built in Summit, NJ, starting with 100,000 square-foot science and innovation and expected to open in 2025.  It announced adding Russell Dyer as chief corporate affairs officer starting 13 March.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS100858

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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