The FDA has published a proposed rule to codify the agency’s views on when a change to the labeling of an approved drug, biologic, or medical device may be made in advance of the FDA’s review of the change. The rule would codify that a supplemental application is appropriate only to reflect newly-acquired information. It also would clarify that a supplemental application may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction only if there is sufficient evidence of a causal association with the drug, biologic, or device. This proposed rule is viewed by many as FDA’s attempt to address preemption questions raised in state product liability lawsuits against holders of marketing applications for their failure to amend labeling before or without FDA’s approval. Comments will be accepted until March 17.