Professional Product Labeling; Public Meeting

Streszczenie

The Food and Drug Administration (FDA) is announcing an open public meeting to discuss prescription drug product labeling designed for health care professionals. The purpose of this meeting is to present background information and research concerning how approved prescription drug product labeling (package inserts) may be adapted to communicate more effectively to professional users, especially health care practitioners in clinical practice. FDA has developed an initial prototype of approved product labeling that summarizes the important information in drug product labeling and reorganizes existing sections. FDA is seeking comments on the value of these possible revisions to professional product labeling, and therefore FDA encourages interested individuals to attend this meeting to obtain relevant information on which to base their comments.