FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: M4Q(R2) THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY; INTERNATIONAL COUNCIL FOR HARMONISATION; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Jan. 21 -- Food and Drug Administration has issued a notice called: M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; International Council for Harmonisation; Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on Jan. 21 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality." The draft guidance was prepared under the auspices of the International Council for ...