Life Sciences

FDA's final guidance clarifies reprint guidelines

Device Regulation Alert: Safety, Compliance and Reimbursement News, February 16, 2009

In January, the FDA provided some much needed guidance for the medical device industry about when companies can properly distribute reprints containing information about off-label and investigational uses of products.

According to the guidance, companies can distribute a scientific or medical journal article or reference publication that addresses scientifically sound clinical investigations. Articles must be in the form of an unabridged reprint, copy of an article, or reference publication and accompanied by the approved labeling and a comprehensive bibliography.

Download our free white paper, FDA Finalizes Guidance on Distribution of Reprints, for more information about the guidance.

Most Popular