WASHINGTON, Sept. 9 -- Food and Drug Administration has issued a notice called: E6(R3) Good Clinical Practice; International Council for Harmonisation; Guidance for Industry; Availability.
The notice was published in the Federal Register on Sept. 9 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 final guidance for industry entitled "E6(R3) Good Clinical Practice." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes a principles document and annex 1 and is the precursory guidan...