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

Procter & Gamble’s psyllium cholesterol-lowering claim

Executive Summary

Via a May 11 letter, FDA gives the go-ahead for use of a protocol for a 34-week, double-blind, placebo-controlled, multisite, parallel, clinical study of psyllium's effect on reducing cholestrol levels. P&G, marketer of the psyllium-containing laxative Metamucil, previously submitted data on psyllium which FDA determined was insufficient to support a cholesterol-lowering claim. FDA said that the study objectives "are clear and the protocol should provide adequate data for statistical analysis of end-point efficacy and safety variables." But FDA added that the study "is not intended to address the questions of dose response and mechanism of action" and the agency made suggestions for minor modifications.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS017515

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