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.
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