WASHINGTON, June 2 -- Food and Drug Administration has issued a notice called: M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on June 2 by Grace R. Graham, 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Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Te...