WASHINGTON, Dec. 1 -- Food and Drug Administration has issued a notice called: Q3E Guideline for Extractables and Leachables; International Council for Harmonisation; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on Dec. 1 by Lowell M. Zeta, Acting, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Q3E Guideline for Extractables and Leachables" and a draft supporting document entitled "Supporting Documentation: Class 3 Leachable Monographs." The draft guidance and supporting document were prepared under the auspices of the International Counc...