Regulatory Guidance

The FDA enforces strict regulations on all aspects of prescription drug research, manufacturing and marketing. In order to assist the industry with compliance, the FDA periodically issues guidance documents that clarify and explain the detailed requirements and actions that companies must perform. The following guidance documents provide information specific to advertising and marketing. They are available for download from the FDA Web site: http://www.fda.gov/cder/ guidance/guidance.htm. Please see the "Drug Regulation'' chapter for additional regulatory resources and a comprehensive overview of the drug approval process.

U.S. Department of Health and Human Services, FDA. Guidance for Industry: Accelerated Approval Products— Submission of Promotional Materials (Draft Guidance). March 1999. URL: http://www.fda.gov/cder/guidance/2197dft. pdf [24 October 2005].

U.S. Department of Health and Human Services, FDA. Guidance for Industry: Consumer-Directed Broadcast Advertisements. August 1999. URL: http://www.fda.gov/cder/guidance/ 1804fnl.htm [24 October 2005].

U.S. Department of Health and Human Services, FDA. Guidance for Industry: Industry-Supported Scientific and Educational Activities. November 1997. URL: http://www.fda.gov/ cder/guidance/isse.htm [24 October 2005].

U.S. Department of Health and Human Services, FDA. Guidance for Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (Draft Guidance). January 1999. URL: http://www.fda.gov/cder/ guidance/1955dft.pdf [24 October 2005].

U.S. Department of Health and Human Services, FDA. Guidance for Industry: Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs) (Draft Guidance). December 1997. URL: http://www.fda.gov/cder/guidance/1726dft.pdf [24 October 2005].

U.S. Department of Health and Human Services, FDA. Guidance for Industry: Disclosing Risk Information in

Consumer-Directed Print Advertisements (Draft Guidance). February 2004. URL: http://www.fda.gov/cder/guidance/ 5669dft.pdf [24 October 2005].

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