Zdrowie i gospodarka · 10/8/1996
Advertising and Promotion; Guidances
The agency is publishing two guidances entitled ``Guidance to Industry on Dissemination of Reprints of Certain Published, Original Data'' and ``Guidance for Industry Funded Dissemination of Reference Texts.'' These guidances relate to the dissemination, by sponsors of human and animal drugs, medical devices, and biological products of certain reprints of journal articles and reference texts (medical textbooks and compendia), which contain information concerning FDA- approved products that may not be consistent with the approved labeling for the products. These guidances describe the circumstances under which the agency intends to allow the dissemination of these reprints and reference texts to health care professionals. These guidances are intended to assist the agency in fulfilling its mission to help ensure the safety and effectiveness of human and animal drugs, medical devices, and biological products. The full texts of these guidances are published in this document.