Pregnancy labeling due date nears
Executive Summary
A proposed regulation on the format and content of drug labeling to address pregnancy and lactation issues could be published this month, according to the HHS Semiannual Regulatory Agenda. Published in the May 5 Federal Register, the agenda sets a May 2008 target date for the proposed rule, which is intended to convey more clearly the risks to a fetus or newborn from a mother's use of a drug (1"The Pink Sheet," Jan. 7, 2008, In Brief)