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Guidance on Industry-Supported Scientific and Educational Activities
JAMA. 1998;279:346.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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The FDA has issued a guidance for industry that seeks to clarify the distinction drawn by the agency between scientific and educational activities that the FDA considers nonpromotional and those that the agency considers promotional, and to provide guidance on how industry may support such activities without subjection to regulation under the labeling and advertising provisions of the Federal Food, Drug, and Cosmetic Act. The draft version of the guidance was published for public comment in 1992.
The fundamental principle of the final guidance is to focus on the FDA's core concern that the provider of scientific and educational information develop the subject program independent from the influence of the supporting company and that there is disclosure of relationships between and among the supporting company, provider, presenters, and products discussed that may be relevant for health professionals to assess the information presented. The final guidance describes factors that the agency . . . [Full Text of this Article]
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