FDA Issues Final Guidance for Drug and Device Industry on Off-Label Reprint Practices

January 20, 2009
The FDA recently released its guidance for the drug and device industry regarding “Good Reprint Practices” for distributing medical or scientific articles about new, unapproved “off-label” uses of approved drugs and medical devices. This update summarizes the new guidance, which is the FDA’s attempt to strike a balance between avoiding the potential pitfalls of promoting drugs and medical devices for unapproved uses, while imparting important and potentially life-saving information for patients.