United States of America. The Food and Drug Administration is publishing a draft guidance entitled “Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products”. The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It is intended to assist in the establishment of a uniform set of international specifications for biotechnological and biological products to support new marketing applications.
Copies of the draft guidance are available from the Drug Information Branch (HFA-210) Center for Drug Evaluation and Research, FDA, 5600 Fishers Lane, Rockville MD 20857, USA or from the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), 1401 Rockville Pike, Rockville MD 20852-1448, USA (with one self-addressed adhesive label) or from the Internet at: http://www.fda.gov/cder/guidance/index.htm.
Reference(s): Federal Register 63(110): 31506-31513 (1998).