Why is FDA changing the content and format of prescribing information for drugs?
These changes are part of a larger FDA initiative to manage the risks of medical product use and reduce medical errors by healthcare professions, as well as enable them to better communicate risk information to their patients. Developments in recent years have contributed to an increase in the length, detail, and complexity of prescribing information for drugs. The revisions will make it easier for healthcare professionals to access, read, and use prescribing information, thereby increasing the extent to which they rely on it to obtain information on prescribing, dispensing, and administering prescription drugs. These revisions should enhance the safe and effective use of prescription drug products and in turn reduce the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information. • What is the “prescribing information” for drugs that will have to be revised? Prescribing information is also known as “labeling,” “package inse
