FDA has proposed a new, user-friendly format for the package inserts that give physicians information on prescription drugs. FDA believes the new labeling format will help reduce medical errors in drug prescribing.

Product labeling represents a primary way to share critical drug information with physicians, and one FDA study revealed that practitioners found current labeling lengthy, complex, and hard to use. The proposed labeling will cut down the time physicians spend looking for information and make it easier to spot warnings. One major proposed change is the addition of a bulleted "Highlights" section that would include information that practitioners consider most important and need to refer to frequently.

Because these labeling changes are most critical for newer and less familiar drugs, the proposal will apply only to relatively new prescription drug products. FDA reviews and approves drug product labeling that manufacturers propose.