Pink Sheet is part of the Business Intelligence Division 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

Psyllium

Executive Summary

FDA OTC Drug Evaluation Director Gilbertson informs Procter & Gamble that a study on psyllium as a cholesterol-lowering agent proposed in a March 23 letter appears to "provide adequate data for statistical analysis of endpoint efficacy and safety variables, dietary and test drug compliance data." However, Gilbertson notes that the study will not provide information on dose response or the mechanism of action, two questions of interest to FDA.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS017551

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