Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability

Zusammenfassung

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products--Content and Format." This guidance is intended to assist applicants in writing the DRUG ABUSE AND DEPENDENCE section of the labeling, as described in the regulations for the content and format of labeling for human prescription drug and biological products. The recommendations in this draft guidance will help ensure that the labeling is clear, concise, useful and informative, and, to the extent possible, consistent in content and format within and across drug and therapeutic classes.