FDA's Guidance for Industry Consumer-Directed Broadcast Advertisements

FDA's Guidance for Industry Consumer-Directed Broadcast Advertisements

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Guidance for Industry Consumer-Directed Broadcast Advertisements U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) August 1999 DDMAC
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Guidance for Industry Consumer-Directed Broadcast Advertisements Additional copies of this Guidance are available from: Office of Training and Communications Division of Communications Management Drug Information Branch, HFD-210 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane, Rockville, MD 20857 (Phone 301-827-4573) Internet: http://www.fda.gov/cder/guidance/index.htm. or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 Internet: http://www.fda.gov/cber/guidelines.htm. Fax: 1-888-CBERFAX or 301-827-3844 Mail: the Voice Information System at 800-835-4709 or 301-827-1800 or Communications Staff (HFV-12) Center for Veterinary Medicine (CVM) 7500 Standish Place, Rockville, MD 20855 (Tel) 301-594-1755 http://www.fda.gov/cvm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) August 1999 DDMAC
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This guidance has been prepared by the Intra-Agency Group on Advertising and Promotion at the Food and 1 Drug Administration. This guidance represents the Agency’s current thinking on procedures to fulfill the requirements for disclosure of product information in connection with consumer-directed broadcast advertisements for prescription human and animal drugs, and human biological products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance is not intended to cover the advertising of restricted medical devices, which are subject to the 2 requirements of section 502(r) of the Federal Food, Drug, and Cosmetic Act. GUIDANCE FOR INDUSTRY 1 Consumer-Directed Broadcast Advertisements I. INTRODUCTION This guidance is intended to assist sponsors who are interested in advertising their prescription human and animal drugs, including biological products for humans, directly to consumers through broadcast media, such as television, radio, or telephone communications systems. 2
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This note was uploaded on 04/13/2010 for the course PSYCH 101 taught by Professor Gabbart during the Spring '08 term at Union College.

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FDA's Guidance for Industry Consumer-Directed Broadcast Advertisements

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