New Product Labeling: A Movement toward Increased Patient Safety

Department of Health and Human Services. Food and Drug Administration. Requirements on content and format of labeling for human prescription drug and biological products. 21 CFR Parts 201, 314, and 601. [Docket No. 2000N-1269] Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/06-545.pdf. Accessed March 28, 2006.

The Food and Drug Administration. New requirements for prescribing information. February 3, 2006. Available at: http://www.fda.gov/cder/regulatory/physLabel/default.htm. Accessed March 28, 2006.