Healthy Skepticism Library item: 6614

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: report

Food and Drug Administration
Advertising and promotion; draft guidances
1995 Dec 6

Abstract:

The Food and Drug Administration is publishing two draft guidances related to the dissemination by sponsors of human and animal drugs, medical devices and biological products, of certain reprints of journal articles discussing FDA-approved products, and reference texts (medical textbooks and compendia). The draft guidances describe circumstances under which the agency would exercise its discretion to allow the dissemination of these reprints and reference texts to health care professionals.

Keywords:
*policy statement & guideline/United States/Food and Drug Administration/FDA/regulation of promotion/ unlabeled indication/ company supplied articles/ doctors/INFORMATION FROM INDUSTRY: DOCTORS/PROMOTIONAL TECHNIQUES: UNLABELED INDICATIONS/REGULATION, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION