The Food and Drug Administration (FDA) is announcing the availability of and seeking public comment on a draft guidance for industry entitled “Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.”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 The recommendations in this draft guidance will help ensure that the labeling is clear, concise, useful and informative, and, to the extent possible, consistent in content and format within and across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.
This draft guidance is one in a series of guidances FDA is developing or has developed to assist applicants with the content and format of labeling for human prescription drug and biological products. In the Federal Register of January 24, 2006 (71 FR 3922), FDA published a final rule on labeling for human prescription drug and biological products. The final rule and additional guidances on labeling can be accessed online. The labeling requirements and these guidances are intended to make information in prescription drug labeling easier for health care practitioners to access, read, and use.