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FDA : commentaire public Wanted sur des aperçus d'arrangement du consommateur

par Astrid Fiano , DOTmed News Writer
The U.S. Food and Drug Administration is asking for public comment on a plan to collect information through a national consumer survey on understanding the risks and benefits of FDA-regulated medical products.

The FDA said the public needs to understand the risks and benefits of FDA-regulated medical products sufficiently to make rational decisions about product use. Hence, the FDA's responsibility includes communicating about medical products, such as recall notices, warnings, public health advisories and notifications, press releases and information made available on its Web site. The FDA also regulates communications drafted and disseminated by manufacturers and distributors of medical products, such as advertising and labeling. The FDA therefore wants to collect research and studies relating to health information, including the use of nationally representative surveys of consumers, to assess whether the information the FDA or its entities regulates reaches targeted audiences, and is understood.

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The FDA plans to administer parallel surveys to 1,500 non-institutionalized U.S. adults by telephone and Internet. The results will be used for insight into the best methodology for future studies. The surveys will cover public understanding about the benefits and risks of medical products and FDA's role in regulating these products, as well as perceptions of the FDA and other potential sources of risk and benefit information. The data collected will be used by FDA in the development of more effective risk communication strategies and messages.

The FDA is specifically seeking comments on the following: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques and other forms of information technology.

Comments can be submitted either electronically or in writing, by December 6, 2010, to http://www.regulations.gov or to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2010-N-0502.

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