United States of America. The Food and Drug Administration has announced the availability of a draft guidance for industry entitled “General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products”. This document is intended to assist applicants who plan to conduct pharmacokinetic studies in children so that drugs and biological products can be labelled for use in children.
Copies of the draft guidance are available from the Drug Information Branch, (HFM-210), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville MD 20857, USA (with one self-addressed adhesive label) or from the Internet at: http://www.fda.gov/cder/guidance/index.htm.
Reference: Federal Register 63(229): 65794-5 (1998).