Pink Sheet is part of the Informa 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

Oral polio vaccine neurovirulence tests

Executive Summary

Lederle files petition with FDA on June 7 seeking a stay of action on the effective date of the agency's recently published rule on neurovirulence testing standards for oral polio vaccine. On the same day, Lederle also filed objections and request for a hearing on the OPV test standards. FDA's OPV final rule, published May 8, was essentially a compromise measure that permitted use of both WHO test standards, sought by Connaught, and the U.S. standard used by Lederle for the past 25 years ("The Pink Sheet" May 20, T&G-6). Lederle maintains that "any change in safety testing for [OPV] must be justified by a conclusive demonstration that the new test is at least as good as the old".
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS019305

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