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

FDA/Lederle/Connaught OPV testing standards meeting

Executive Summary

Commissioner Young met with representatives from both companies to discuss a proposal for the Oral Polio Vaccine testing standards. He indicated that the agency may modify intraspinal tests to conform to World Health Organization standards. Young also said that the intrathalamic test of the US Standards may be retained. At FDA's Vaccines and Related Biological Products Advisory Committee held Jan. 29-30, FDAer Gerald Quinnan, MD, stated that the intrathalamic tests in monkeys might be eliminated under the proposed changes in standards ("The Pink Sheet" Feb. 2, p. 9). Young asked Lederle and Connaught to comment on the option.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS012242

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