On May 29, 2008, the Food and Drug Administration (FDA) published a proposed rule to make major revisions to drug label requirements related to the use of a drug during pregnancy and breast feeding. Among other things, the agency is proposing to require that labeling include a summary of the risks of using a drug during pregnancy and lactation and a discussion of the data supporting that summary. The labeling also would include relevant clinical information – presented in sections on fetal risks, clinical considerations, and data – designed to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and/or lactation. Current letter categories would be removed from the pregnancy section of drug labeling. Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling requirements for previously approved drugs will be phased-in. The FDA is accepting comments on the proposal until August 27, 2008.