United States of America. The Food and Drug Administration has announced the availability of a draft guidance document entitled “Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Virus Type 1”. The draft guidance document addresses general and specific concerns for gene based detection techniques, and it is intended to provide guidance on manufacturing and clinical trial design issues pertaining to the validation of tests based on nucleic acid detection either in the presence or absence of an amplification step.
Copies of the draft guidance are available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), 1401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/cber/guidelines.htm.
Reference(s): Federal Register 63(132): 37402-3 (1998).