TAILIEUCHUNG - Prescription Drug Marketing Act (PDMA) Requirements

Customer loyalty is of utmost importance to apparel and footwear manufacturers, who would do almost anything to attract new customers while trying to keep existing customers. “In a market that bombards consumers with advertising campaigns and lifestyle and fashion messages, a brand name is a powerful weapon in these efforts” (Wagle). Brand names are becoming increasingly important to consumers as disposable income and the amount of time consumers are able to shop around is slowly diminishing. Therefore consumers are relying more on established brand names and the images they convey when purchasing products. From the manufacturer’s. | Contains Nonbinding Recommendations GUIDANCE FOR INDUSTRY Prescription Drug Marketing Act PDMA Requirements Questions and Answers . Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of the Commissioner Office of Regulatory Affairs November 2006 1 Contains Nonbinding Recommendations GUIDANCE FOR INDUSTRY Prescription Drug Marketing Act PDMA Requirements Questions and Answers Additional copies are available from Additional copies 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 cder guidance . Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of the Commissioner Office of Regulatory Affairs November 2006 2 Contains Nonbinding Recommendations Guidance for Industry1 This guidance represents the Food and Drug Administration s FDA s current thinking on this topic. It does not create or confer any rights on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate staff call the appropriate number listed on the title page of this guidance. I. Introduction The Prescription Drug Marketing Act of 1987 PDMA amended by the Prescription Drug Amendments of 1992 PDA requires among other things that certain wholesalers provide a statement also known as a pedigree prior to each wholesale distribution of prescription drugs. This guidance provides questions and answers relating to the requirements set forth in 21 CFR Parts 203 and 205 and other Parts .

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