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GUIDANCE DOCUMENT

Industry Supported Scientific and Educational Activities Guidance for Industry November 1997

Final
Issued by:
Guidance Issuing Office
Office of Policy

Two important sources of information on therapeutic products (human and animal drugs, biological products, and medical devices regulated by the Food and Drug Administration) for health care professionals are (1) Activities (programs and materials) performed by, or on behalf of, the companies that market the products; and (2) activities, supported by companies, that are otherwise independent from the promotional influence of the supporting company. Although both provide valuable and sometimes vital information to health care professionals, the programs and materials performed and disseminated by companies are subject to the labeling and advertising provisions of the Federal Food, Drug, and Cosmetic Act, whereas the truly independent and nonpromotional industry-supported activities have not been subject to FDA regulation.

 


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.